Platelets Pheresis Leukocytes Reduced Washed
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood product, manufactured from Whole Blood unit with an extended collection time, was distributed
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Screw Tulip , 6.25mm Rod   Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
5.5mm x 30mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 35mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 40mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 45mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 50mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 55mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 30mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 35mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 40mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 45mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 50mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 55mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 30mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 35mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 40mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 45mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 50mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 55mm Cannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
Screw Tulip , 5.5mm Rod   Subsequent Codes: KWP, KWQ, MNH, MNI
4.5mm x 35mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
4.5mm x 40mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 40mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 45mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
5.5mm x 50mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 40mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 45mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
6.5mm x 50mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 40mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 45mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
7.5mm x 50mm Noncannulated Screw Shank   Subsequent Codes: KWP, KWQ, MNH, MNI
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
''Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)''
''***Avena de Aqu Si Azucar Aadida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Catao PR 00962***''
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ  08543; UPC 3 10310 32370 7.
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Distributed to Whole Foods Grocery chain only with nationwide locations including Rocky Mountain, Northeast, North Atlantic, Mid Atlantic, Northwest, and Southwest.
Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
6 x 5 lb units and 35 x 7oz cases (420 units)
Sartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Mediterranean Tapenade packaged in 7 oz clear plastic and 5 lb capacity white plastic tubs, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
27 cases (324 units) - 7 oz; 18 x 5 lb units
Tex Mex Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Jalapeno Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Mango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Spinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Famous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Salsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Nationwide Distribution including AL, CA, CO, OK and GA.
RotoRest Delta Kinetic Therapy System   INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack.  KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack.  In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat.   Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step.  Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe.  This small amount of blood (approximately 0.2 mL) would then migrate to the bottom of the centrifuge cup after the 2 minute centrifuge spin cycle.
USA (nationwide) including the states of  AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)   The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
Firm has received complaints from customers of ''Abnormal Reaction'' errors occurring on calibrations, QC and patient samples.  The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.
IO Fix IntraOsseous Fixation System; Extremity Medical.  www.extremitymedical.com; Customer Service: 888.499.0079.   The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Worldwide Distribution--USA (nationwide) and the countries of  Germany, Canada and Australia.
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control.    Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument.  .
MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date:  OIM-101 - OIM14031 - 31 MAR 2014;  OIM-202 - OIM14032 - 31 MAR 2014;  OIM-303 - OIM14033 - 31 MAR 2014;  OIM-SP - OIM1403S - 31 MAR 2014.    MAS Omni IMMUNE PRO:  OPRO-101 - OPRO14031 - 31 MAR 2014;  OPRO-201 - OPRO14032 - 31 MAR 2014'  OPRO-303 - OPRO14033 - 31 MAR 2014;  OPRO-SP - OPRO1403S - 31 MAR 2014.
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Goshen, IN, Hillsboro, WI, and Reedsburg, WI.
DFA (Dairy Farmers of America), non-fat dry milk intended and labeled as animal feed 50 lb bags
The product may be contaminated with Salmonella.
Worldwide distribution: USA (nationwide) and countries of:  Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5  00789502220 VerSys Femoral Head Provisional 22mm -2  00789502230 VerSys Femoral Head Provisional 22mm +3  12/14 Neck Taper    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
All lots distributed from lot 69998600 (2/20/1996) to present
Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head.  The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0  00789502603 VerSys Femoral Head Provisional 26mm +3.5  00789502604 VerSys Femoral Head Provisional 26mm +7  00789502605 VerSys Femoral Head Provisional 26mm +10.5  12/14 Neck Taper  The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0  00789502803 VerSys Femoral Head Provisional 28mm +3.5  00789502804 VerSys Femoral Head Provisional 28mm +7  00789502805 VerSys Femoral Head Provisional 28mm +10.5  12/14 Neck Taper    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0  00789503203 VerSys Femoral Head Provisional 32mm +3.5  00789503204 VerSys Femoral Head Provisional 32mm +7  00789503205 VerSys Femoral Head Provisional 32mm +10.5  12/14 Neck Taper    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0  00789503603 VerSys Femoral Head Provisional 36mm +3.5  00789503604 VerSys Femoral Head Provisional 36mm +7  00789503605 VerSys Femoral Head Provisional 36mm +10.5  12/14 Neck Taper    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0  00789504003 VerSys Femoral Head Provisional 40mm +3.5  00789504004 VerSys Femoral Head Provisional 40mm +7  00789504005 VerSys Femoral Head Provisional 40mm +10.5  The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22  00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26  00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26  00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26  00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28  00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28  00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28  00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28  00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32  00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32  00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32  00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32  00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36  00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36  00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36  00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36  The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36  00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36  00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36  00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36  The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
US Nationwide including the states of: MA and TX.
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223      Product Usage:  Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient.  The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: ''Care is to be taken to not over insert the Implant Guides past the disc space as this could result in the possible misplacement of the implant and/or possible harm to the patient.''
Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
''***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9'')***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***''.   This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
''***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9'')***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***''.   This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
S8585 (8.5MM Drill Bit), lot number 322287
Worldwide Distribution - USA nationwide  including the states of:  AK, CA, IL, FL, HI, MI, MO, NC,  NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
Multipolar Bipolar Cup Liner 22 mm LD.;  Item 00-5001-040-22    Product Usage:  The liner snaps into the Multipolar Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
Zimmer Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
USA (nationwide) including the states of Ohio, Carolinas and New England.
Trilogy II  Constrained Liner    The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons.  The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
PEACHEY'S 20/20 AM NM MILK REPLACER,''ALL MILK'',  Manufactured for: Peachey's 638 Bunker Hill Road, Belleville, PA #122, NET WEIGHT 50 LBS (22.7Kg).
Quality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
YO-MOMMA 26/24 AM NM MILK REPLACER., Manufactured for Agri Support Inc., 8137 Royal Oaks Road, Rockford, IL 61107 #126, NET WEIGHT 50 LBS (22.7 Kg).
QUALITY FEEDS INCORPORATED 20/20 AM, ., Manufactured for Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118 Pin #2021, NET WEIGHT 50 LBS (22.7 Kg).
DAIRY PRINCESS ''ACCELERATED'' ,  23/18 AM MILK REPLACER MEDICATED, Manufactured for Nelson Dairy Consultants, Inc., Holtz Nelson Dairy Consultants, LLC., 115 Washington Street, Decorah, IA 52101 #208,  NET WEIGHT 50 LBS (22.7 Kg).
QUALITY FEED INC.,  STARTER PLUS, 20/17 , MILK REPLACER, Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg).
QUALITY FEED INC.,  FINISHER PLUS 16/18 , MILK REPLACER , Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg).
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Spine Frontier Inspan compressors Part Number: 11-60004.    Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Inspan Compressors may break at weld causing a loss of compression
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, which may have been exposed to unacceptable temperature during storage, was distributed.
Blood products, which were not quarantined subsequent to receiving post- donations information, were distributed.
Blood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Blood product, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA  92880 USA, NDC 00591-0540-05.
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Blood products, not prepared according to specifications, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, left in shipping container and was exposed to unacceptable temperatures, was distributed.
Mindray DS USA, Inc. d.b.a. Mindray North America
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
Mindray A3 Anesthesia Delivery System  Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430      This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Mindray A5 Anesthesia Delivery System  Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430    This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems.  A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ  08876 USA      Ref 2993      SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
PMA: P990004 Medical Device Listing Number:  D100622    Product Code 2993    Lot/Batch Numbers:   239346  Exp Jan-13  239411  Exp Jun-13
SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ   08876, USA   SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
PMA number P990004    Medical Device Listing Number  D100622    Product Code:  2991    Lot #  239091    Exp Mar-13  Lot #  238783    Exp Sep-13  Lot #  238635    Exp Mar-13  Lot #  237498    Exp Mar-13  Lot #  237119    Exp Mar-13  Lot #  235488    Exp Jan-13
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, with incorrectly transcribed platelet counts, were distributed.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
Stryker Orthopaedics  Torx 6.5mm  Cancellous Bone Screw  Ref 2030-6525-1    The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Catalog No: 2030-6525-1 Lot Code: MLHYL7, MLJT50  Ref 2030-6525-1
Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix.  Packaging associated with a 35 mm screw may contain a 25mm screw.  Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
Stryker Orthopaedics  Torx 6.5mm  Cancellous Bone Screw  Ref 2030-6535-1    The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT  Ref 2030-6535-1
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Stryker XIA 3 TORQUE WRENCH   REF 48237028    Manufactured by:  Stryker pine SAS  Z.I MARTICOT-33610-CESTAS-FRANCE  +33 (0)5.57.97.06.30  http://www.stryker.com    Distributed in the USA by:  Stryker Spine,  2 Pearl Ct. Allendale  NJ 07401-1677 USA  +1-201-780-8000    The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible ''click'' when the desired final tightening torque is reached.
Class I device, 510(K) exempt   Catalog Number: 48237028  Lot Number: 093653, 093654, 093655
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Stryker MANTIS TORQUE WRENCH   REF 48287028    Manufactured by:  Stryker pine SAS  Z.I MARTICOT-33610-CESTAS-FRANCE  +33 (0)5.57.97.06.30  http://www.stryker.com    Distributed in the USA by:  Stryker Spine,  2 Pearl Ct. Allendale  NJ 07401-1677 USA  +1-201-780-8000    The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible ''click'' when the desired final tightening torque is reached.
Class I device, 510(K) exempt   Catalog Number: 48287028  Lot Number: 098400
SPECIALTY AUDIBLE TORQUE WRENCH, XIA   IS2217XLP      MFG BY: STRYKER SPINE  2 PEARL COURT  ALLENDALE NJ 07401-1677    The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible ''click'' when the desired final tightening torque is reached.
Class I device, 510(K) exempt   Catalog Number: IS2217XLP  Lot Number: 2576, 2756
Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA.  Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA.
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01,  Clinical instrument software, English, Spanish, Italian, catalog number 411814   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02,  Clinical instrument software, English, Spanish, Italian, catalog number 411815   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01,  Clinical instrument software, Chinese, catalog number 411816   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03,  Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04,  Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05,  Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06,  Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01,  Clinical instrument software, English, Spanish, Italian, catalog number 411818   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02,  Clinical instrument software, German, French, Swedish, catalog number 411925   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622   Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument   The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484   Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI.  Distribution was also made to Canada, military facilities and other foriegn countries.
0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter   Product Usage:  The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.
The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
Vital Signs Devices, a GE Healthcare Company
Worldwide distribution: USA (nationwide) including states:  AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0     A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Dannon Activia LIGHT Nonfat Yogurt Peach Flavor, Each unit 4-pack of 4-oz cups/6, 4-count pack to a case (24 cups/case)  UPC 3663202633
Expiration Code NOV 07 2012 MZ, Expiration Code NOV 09 2012 MZ,  Expiration Code NOV 10 2012 MZ
Distribution was made to two distribution centers one in TX and one in NC. Further distribution to retail stores was made to SC, GA, FL, TN, VA, WV, KY, OH and PA.
Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO)
Bag label: UPC 79801-24630  Best Buy Code: JUL 17 13 J8   Case label: UPC 79801-24632  Best Buy Code: JUL 17 13 JB
The Better Valu Fruit Whirls contain undeclared almond butter.
Innovative Magnetic Resonance Imaging Systems Inc.
Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
US states: CA, AZ, NV, TX, CO, ID, MO, NJ, NM, OK, UT.    No international consignees.
Salted in-shell Peanuts under the following.   Salted in Shell PeanutsGless Ranch Label, Item Number 450-175, Pack Size 24/12 oz bags, UPC Code 72488980310.    Salted in Shell PeanutsSun Harvest Label, Item Number 450-248, Pack Size 24/16 oz bags, UPC Code 646670306785.    Salted in-shell Peanuts, Item Number 450-195, 50 lb Bulk Bag, UPC Code none.    Salted in-shell PeanutsTorn and Glasser bulk case, Item Number 450-185,  25 lb Bulk Case, UPC Code none.    Salted in-shell PeanutsTorn and Glasser retail label, Item Number 450-245, Pack Size 24/1 lb, UPC Code 72488858664.    Salted in Shell PeanutsSprouts label, Item Number SP450-185, Pack Size 25 lb case/12bags, UPC Code 206561XXXXXX (last 6numbers change for each package -random weight).
Torn and Glasser, Inc of Los Angeles, CA 90021 is voluntarily recalling Salted in-shell product (packaged after November 9, 2011), and one lot of Organic Peanut Butter (packaged January 13, 2012) because they contain recalled peanuts and peanut butter received from Sunland, Inc., and have the potential to be contaminated with Salmonella,
Organic Peanut Butter, Item Number 342-007, Pack size 12/14oz tubs. No UPC code. Product labeling:'' ''.
Lot 0132 (produced January 13, 2012). Lot code marking can be found on the side  label.
qube Compact Monitor (Patient Monitor) 91390.  The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs).  It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution.     The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
742 total devices distributed; 530 with the U.S. and 212 Internationally.
Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor  will go on battery mode. The monitor will function  normally until the batteries become depleted and then  the monitor will shut down.  In addition the monitor may  fail to turn on due to an internal short.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457.   The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461.   The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102.   The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Serial Numbers: Included in the corresponding Dxl system.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, Australia, and Europe.
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470.   Freedom Cordless LED Light System is a Class I Medical Device. The device  listing number this product is E115952.    The intended use of this device is to illuminate oral structures and operating areas.
Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470.     Freedom Cordless LED Light System has no expiration date. The affected units  were produced and distributed since February 2011.
The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
Worldwide Distribution--USA (nationwide) and the countries of  Canada and EU.
The brand name of the device is Laser Loupes, a dentalloupe  with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices.    Laser Loupes are  available with four (4) different filters of different colors. Each colored filter is  associated with specific laser frequency ranges. The device listing number for this product is E160359.    The intended use of this device is to magnify the operatory field and provide laser eye protection.
The Laser Loupes are custom made-to-order products.    There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008.
The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to  the device.
Nationally and global including Cuba and Puerto Rico.
Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing.
Rudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects.
Rudi's Organic Bakery, Multigrain Oat Bread, 22 oz, UPC 031493-82888-8, packed in flexible plastic bags.  Labeling is tan, yellow, white, maroon, and orange with maroon, green, black, white, and orange print writing.
Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing.
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets.   Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India    NDC 55111-249-05
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Horiba Instruments, Inc dba Horiba Medical
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).   Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents
Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High).  Customer communication was sent 10/01/2010.
Worldwide Distribution--USA (nationwide)  including the states of  AL, CA, CT, KS, MA,  MD, MN, MO, NY, SD, TX and WI  and the countries of  Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
The Trilogy Acetabular System Shell with Cluster Holes   Porous 56 mm  O.D. Sterile     The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
All states except Vermont and Wyoming plus Washington, DC and Puerto Rico; Canada was the only other country.
Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
This is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092).   Some jars of fennel seeds have been found to contain small, red beetle-type insects.
American Enterprises LLC dba Sterling Gelatin
Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164.  MADE IN INDIA
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
4.5mm PLEO Osteotomy Guide.   OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc system. The PediLoc Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the  FDA and is classified as a Class II Medical Device.   BioPlant is a Class II Medical Device. The Device Listing Number is 0007254.    BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
The BioPlant part numbers and lot numbers affected by this recall are as follows:   Product Description                       Part Numbers    Lot Numbers       SioPlant Curved Syringe, 0.125g    216110    All Production       SioPlant Curved Syringe, 0.25g    216112       SioPlan! Curved Svrinoe, 0.50<1    216114    Lots Within Shelf-Life      BioPlant Curved Svrinoe, 0.250    216132       20k      BioPlant Intro Pack       216112S
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile.  Size 2 / Infant Silicone King LAD Patient Size: 10-20kg     Product Usage:  Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change.  The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle.  The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd.  The firm segregated the affected lots of King LAD devices.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD Patient Size: 30-50kg     Product Usage:  Laryngeal airway
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD Patient Size: 50-70kg
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >70kg    Product Usage:  Laryngeal airway
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD Patient Size: 30-50kg     Product Usage:  Laryngeal airway
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD Patient Size: 50-70kg    Product Usage:  Laryngeal airway
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD Patient Size: >70kg     Product Usage:  Laryngeal airway
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie,  20 devices/case Size 2 / Infant ClearSeal Flexible King LAD Patient Size: 10-20kg     Product Usage:  Laryngeal airway
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case ''Size 3 / Child ClearSeal Flexible King LAD Patient Size: 30-50kg ''    Product Usage:  Laryngeal airway
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case ''Size 4 / Adult ClearSeal Flexible King LAD Patient Size: 50-70kg ''    Product Usage:  Laryngeal airway
Worldwide Distribution - USA (nationwide) and the countries of  Saudi Arabia, Thailand, Mexico, Canada, Pakistan,  Israel, Greece,  Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15.    For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30.    For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00.    For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Lot# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66.
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30.   For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Tub labeled as Kay's Classic Vanilla Bean ice Cream.  UPC 87848-13021, 1.5 Quarts (1.42L).  Lid labeled as Kay's Classic Toasted Butter Pecan ice cream
Packaging error.  Toasted Butter Pecan ice cream was packaged in a container labeled as Vanilla Bean.  However the lid on the package did state Toasted Butter Pecan.
Nationwide Distribution including IL and MD
INTRABEAM Balloon Applicator Set; 3.0 cm,  Carl Zeiss Meditec AG, Oberkochen, Germany    INTRABEAM System is intended for radiation therapy treatments
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
INTRABEAM Balloon Applicator Set; 3.5 cm,  Carl Zeiss Meditec AG, Oberkochen, Germany    INTRABEAM System is intended for radiation therapy treatments.
INTRABEAM Balloon Applicator Set; 4.0 cm,  Carl Zeiss Meditec AG, Oberkochen, Germany    INTRABEAM System is intended for radiation therapy treatments.
GE Healthcare Optima XR 200amx with digital upgrade   Mobile general purpose radiographic imaging of the human head and body.
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
GE Healthcare Optima XR 220amx   Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare Optima 200amx   Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare Brivo XR 285   Mobile general purpose radiographic imaging of the human head and body.
Worldwide Distribution -  USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea.
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000).   The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
ROB S/N   GUD S/N   CAM S/N ROB036   GUD054   CAM054  ROB037   GUD043   CAM037  ROB038   GUD038   CAM038  ROB039   GUD039   CAM039  ROB040   GUD040   CAM035  ROB042   GUD042   CAM043  ROB046   GUD046   CAM046  ROB047   GUD044   CAM047  ROB048   GUD047   CAM048  ROB049   GUD048   CAM049  ROB051   GUD074   CAM074  ROB053   GUD053   CAM053  ROB054   GUD091   CAM091  ROB055   GUD055   CAM075  ROB056   GUD056   CAM066  ROB057   GUD058   CAM058  ROB059   GUD059   CAM059  ROB060   GUD060   CAM060  ROB061   GUD061   CAM061  ROB062   GUD063   CAM062  ROB063   GUD062   CAM063  ROB065   GUD065   CAM033  ROB066   GUD057   CAM057  ROB067   GUD067   CAM067  ROB069   GUD036   CAM036  ROB070   GUD070   CAM055  ROB071   GUD083   CAM083  ROB072   GUD072   CAM072  ROB074   GUD102   CAM102  ROB075   GUD103   CAM103  ROB076   GUD045   CAM045  ROB078   GUD082   CAM082  ROB079   GUD076   CAM076  ROB080   GUD071   CAM071  ROB081   GUD075   CAM070  ROB083   GUD069   CAM069  ROB084   GUD100   CAM100  ROB085   GUD079   CAM079  ROB086   GUD086   CAM086  ROB088   GUD088   CAM088  ROB089   GUD089   CAM089  ROB090   GUD080   CAM081  ROB091   GUD098   CAM098  ROB092   GUD051   CAM051  ROB093   GUD085   CAM085  ROB094   GUD094   CAM094  ROB095   GUD095   CAM095  ROB096   GUD125   CAM125  ROB097   GUD097   CAM097  ROB098   GUD093   CAM093  ROB099   GUD099   CAM099  ROB100   GUD081   CAM080  ROB101   GUD101   CAM101  ROB102   GUD077   CAM077  ROB103   GUD078   CAM078  ROB104   GUD104   CAM104  ROB106   GUD106   CAM106  ROB107   GUD107   CAM107  ROB108   GUD108   CAM108  ROB109   GUD109   CAM109  ROB110   GUD110   CAM110  ROB111   GUD111   CAM112  ROB112   GUD105   CAM111  ROB114   GUD113   CAM105  ROB116   GUD115   CAM116  ROB117   GUD116   CAM115  ROB118   GUD117   CAM117  ROB119   GUD118   CAM119  ROB120   GUD119   CAM118  ROB121   GUD120   CAM120  ROB122   GUD121   CAM121  ROB123   GUD122   CAM122  ROB124   GUD123   CAM123  ROB125   GUD124   CAM124  ROB126   GUD126   CAM126  ROB127   GUD127   CAM127  ROB129   GUD129   CAM129  ROB130   GUD130
MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
Grape Tomatoes, 199 cartons x 12 packages x 1 pint.
Ed Produce is recalling grape tomatoes because they may be contaminated with Salmonella.
Nationwide Distribution including CA, IN, NC, OH, and UT.
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated  is a metallic, full-hemisphere, acetabular shell component.    Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm.  The product is sterile.   Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow.  This condition may prevent the driver or abutment from fully engaging in the implant.
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411.  The product is sterile.   Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Worldwide distribution: USA state of Kansas and country of Korea.
PARPARELLA-TYPE VENT TUBE, 1.02 MM,  SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC.,   Tympanostomy tube
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces.  The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only.   The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Lot numbers:  1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D
A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane.  The PCO2 performance of a sensor without electrolyte will be deteriorated.
SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces.  The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only.   The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Lot numbers:  1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
Nationwide Distribution (Distributed to one customer located in MN)
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system.   The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209
Cracker Industries, LLC dba Beagle Bay Organics recalled their Raw Sauerkraut, Kimchi due to a bolt that was found missing from the rotation mixer.