Recalling Firm
Community Blood Bank of Lancaster County Medical Society
Community Blood Center of Greater Kansas City
Mississippi Valley Regional Blood Center
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Busch's, Inc. - Central Production Facility
Mindray DS USA, Inc. d.b.a. Mindray North America

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.
Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
Worldwide Distribution - US Nationwide including the state of OH.
Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
US Nationwide Distribution - including the state of IL.
MI and OH distribution only. Retail only.
Meijer stores in Michigan, Ohio, Indiana, Illinois, and Kentucky
USA Distribution to the state of Florida only.
Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
NY; Expanded on 8/2 to include FL, GA, IL, MD, NC, NJ, PA, SC and VA.
Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Nationwide Distribution - USA including AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY.
Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.
Products were released for distribution in US (PA, TN, IL, CA).
Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
Nationwide Distribution including the state of TN.
Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.
National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Product was distributed to retail stores in California, Oregon and Washington
Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela.
Distribution to food service such as restaurants.
AL, AR, AZ, CA, GA, KS, KY, MD, NC, NM, NV, NJ, PA, SC, TN, TX, VA and WA and Canada.
Worldwide Distribution, including Nationwide (USA).
Distributors in FL, NC, PA, SC, VA, MD and AL
Nationwide in the US: CA, CO, IL, TX, UT

Product Description
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3
Blood and Blood Products for Reprocessing
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
Platelets Pheresis Leukocytes Reduced Irradiated
TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Product is labeled in part: ''***MEDLINE***Extended PTFE Needle 6.5'' (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended PTFE Coated Needle 4.0'' (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0016A -- Lot #: 121808-20. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0'' (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Standard PTFE Coated Needle 2.75'' (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ESE1651 -- Lot # 03059-03 Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0014 -- Lot # 042209-03. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0014AM -- Lot # 050409-05, 050609-05. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.
Product is labeled in part: ''***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***'' Part # ES0014M-- Lot # 050609-05, 052909-05, 062309-04. Product Usage: Intended for cutting and coagulation of soft tissue.
Highline Mushrooms Sliced, white mushrooms 8 oz.
Markets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushrooms, Rosemary, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Markets of Meijer, fresh Grillers Steak Toppers, 10 oz, Ingredients: Red Onions, Mushrooms, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Markets of Meijer, fresh Grillers Aparagus Blend, 14 oz, Ingredients: Asparagus, Sweet Bell Peppers, Mushrooms,, Sweet White Onions, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Apelo Modular Screwdriver labeled in part: ''APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: ''***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
CASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404 4 HORNBACHERS, MAPLE NUT, Ice Cream, HALF GALLON(1.89 L), 0 41130 21666 4 COLUMBIA VALLEY FARMS, MAPLE NUT, 62438, 3 GALLON(11.34L), 0 41493 62438 0
CASS-CLAY, DOUBLE CHOCOLATE FUDGE, Premium Light Ice Cream, HALF GALLON (1.89L), 0 70422 24061 2
Cass Clay, COOKIES 'N CREAM, 1 gallon ( 3.78 L), 0 70422 45034 9 Cass Clay, COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 04010 6
CASS-CLAY: LIGHT DUSTY ROAD, ONE GALLON (3.78 L), 0 70422 23480 2. LIGHT ICE CREAM, DUSTY ROAD, HALF GALLON (1.89L), 0 70422 24080 3
HORNBACHERS, LIGHT FRENCH VANILLA, HALF GALLON (1.89L), 0 41130 21662 6 (Missing Egg from Contains statement) SUNNYBROOK, LIGHT FRENCH VANILLA, HALF GALLON (1.89 L), 0 70422 24917 2 . (MISSING YELLOW 5 FROM LABEL) DAN'S, LIGHT FRENCH VANILLA, HALF GALLON(1.89 L), 0 70422 24317 0 (MISSING YELLOW 5 FROM LABEL )
CASS-CLAY, PRALINE PECAN, 3 GALLON (11.34 L).
CASS-CLAY, BUBBLE GUM, 3 GALLON (11.34 L).
CASS CLAY, DULUTH DARK CHOCOLATE, 3 GALLON (11.34 L).
CASS CLAY, NEW YORK CHERRY ICE CREAM, 3 GALLON (11.34 L).
Dan's, LIGHT BUTTER PECAN, half gallon *(1.89 L), 0 70422 24210 4 Hornbachers, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 41130 21661 9 Sunnybrook, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 70422 24908 0
SunnyBrook, Chocolate Chip one gallon and one quart ( (4.73 L), 0 70422 02905 7 SunnyBrook, CHOCOLATE CHIP half gallon ( (1.89 L), 0 70422 04905 5 Cass Clay, CHOCOLATE CHIP 3 Gallon (11.34 L)
Cass-Clay, UND CHAMPION CHIP, half gallon (1.89 L) 0 70422 04062 5 Cass-Clay, UND CHAMPION CHIP 3 Gallon (11.34 L)
Cass Clay, LIGHT BROWNIE FDG, one gallon ( 3.78 L) 0 70422 23485 7 Cass Clay, LIGHT BROWNIE FUDGE, half gallon (1.89 L) 0 70422 24085 8
Cass Clay CHOCOLATE MONSTER, half gallon (1.89 L) 0 70422 00032 2 Cass Clay CHOCOLATE MONSTER, 3 Gallon (11.34 L) Soy (Lecithin) N/A
Cass Clay, TIN ROOF SUNDAE 3 Gallon (11.34 L) Cass Clay, TIN ROOF SUNDAE, one gallon (3.78 L), 0 70422 03474 7
Cass Clay, BISON CRUNCH, half gallon (1.89 L) 0 70422 04033 5 Cass Clay, BISON CRUNCH, 3 Gallon (11.34 L)
Cass Clay, LIGHT CANDY BAR, half gallon (1.89 L ) 0 70422 24032 2
Cass Clay, LIGHT MUDDY SNEAKERS, half gallon (1.89 L) 0 70422 24072 8
Cass Clay, PEPPERMINT CANDY, half gallon (1.89 L), 0 70422 00100 8 Cass Clay, Peppermint Stic, 3 Gallon (11.34 L).
Cass Clay, WINTER WONDER, half gallon (1.89 L) , 0 70422 00100 8 Cass Clay, Winter Wonder, 3 Gallon (11.334 L)
Schroeder, Ice Cream, Chocolate Chip Cookie Dough, half gallon (1.89 L), 0 72340 00183 2
Hornbachers, Peanut Butter Fudge, Half Gallon, (1.89L), 0 41130-21659 6.
Cass-Clay , Swiss Chip, 3 Gallon(11.34 L).
Cass-Clay, Strawberry Cheesecake, 3 Gallon (11.34 L).
CASS-CLAY, Ice cream, LIGHT MAPLE NUT, One Gallon (3.78L), 0 70422 23404 8
SUNNYBROOK, LIGHT COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 24943 1
Cass-Clay, COOKIES 'N VANILLA 3 Gallon (11.34 L)
HORNBACHERS, FRENCH VANILLA ICE CREAM, Half-gallon (1.89 L), 0 41130 21658 9 (Missing Egg in the Contains statement)
Cass-Clay, BUTTER PECAN, 3 Gallon (11.34 L)
syngo Imaging XS. Radiological image processing system.
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Whole Fresh Cantaloupe, PLU# 4319, Burch Farms, Faison, NC 28341. On 8/2/2012 the recall was expanded to include cantaloupes labeled, Cottle Strawberry, Inc., #4319, Faison, NC. (Cottle Farms is not involved in this recall).
Fresh Whole Honey Dew Melons, packed in paper cartons labeled, Southeastern Growers Association, Fresh Melons. Individual melons were not labeled.
6'' Club Sandwich, 8'' Club Sandwich, Club Sandwich Triangle, and Wide Wedge Club Sandwich
6'' Ham & Cheese Sandwich, 8'' Ham & Cheese Sandwich, and Ham & Cheese Triangle Sandwich
6'' Turkey & Cheese Sandwich, Turkey & Cheese Triangle Sandwich, and Wide Wedge Turkey & Cheese
8'' Roast Beef Sandwich, 6'' Roast Beef Sandwich, Roast Beef Triangle Sandwich, and Wide Wedge Roast Beef Sandwich
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
Sunquest Laboratory LabAccess Results Workstation (LARS)
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
BUSCHS SOUP FROM FOOD BAR Random weight/Sold by the pound
Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
UNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1'' x 1'' cut). Celery Packed by: fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00137
Costa 1/16'' Sliced Onions, 5 lb poly bag (Item # 00254); Costa 1/4'' Sliced Onions, 5 lb poly bag (Item #C50) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Costa Kabob Cut White Onions 1'' x 1'', 5 lb poly bag (Item #00275) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Costa Whole Peeled Onions (Item #00841, #B841) 25 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Costa: 1/2'' Diced Onions (Item #C228); 3/4'' Diced Onions (Item #C244) 1/4'' Diced Onions (Item#C32) 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Legal Seafood Diced Onions 1/16'' (Item #L163) 10 lb poly bag OB Double Diced Onions 1/8'' (item #OB2), 2 lb poly tub
Small Soup Vegetable Mix:-(Item #CC4) Spanish Onions {1/4'' dice), Carrots, Celery Medium Soup Mix Vegetables (Item #CC5) Spanish Onions (1/2'' dice), Carrots. Celery 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Julienne Onions, Item #J705 4.0 lbs poly tub; Legal Onion Strings (Item #L165), 5 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Costa Asian Stir- Fry Blend (Item #SAL3) 5 lb poly bag Spanish Onions {1/4'' Sliced), Red Onions, Green Peppers. Red Peppers, Zucchini, Carrots, Broccoli, Broccoli Stems, Green Cabbage, Pea Pods, Bok Choy Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Costa Four Bean Salad 4.50 lbs Poly Tub (Item #01385 Green Beans, Kidney Beans (kidney beans, water, salt, CaCI2), Chick Peas (chick peas. water. salt, EDTA to promote color retention), Black Eyed Peas (black eye peas, water, salt, calcium chloride and disodium EDTA to preserve color). White Onions, Red Peppers , Italian Dressing (distilled vinegar. soy bean oil. water, com syrup, salt, onion. red bell pepper. xantham gum, spice and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar. salt, citric acid, CaCI2). Onion. While Vinegar and Garlic Powder
Calico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop brand, Item T1407, C1407, 5 lb Poly Bag Black eye peas , water, salt, calcium chloride and disodium EDTA to preserve color), Chick Peas (cooked dried chick peas, water,salt), Kidney Beans (kidney beans, water. salt, CaCI2), Black Beans (black beans, water. salt, CaCI2, ferrous gluconate), Italian Dressing (distilled vinegar, soy bean oil, water, com syrup,salt. onion, red bell pepper, xantham gum. spice and oleo resin paprika, calcium disodium EDTA). Apple Cider Vinegar, Celery, Green Pepper, Red Pepper, Onion
Costa Multiple Bean Salad 4.5 lbs Poly Tub (Item #01407) Black Beans (black beans, water. salt, calcium chloride, ferrous gluconate), Kidney Beans (kidney beans, water. salt, CaCI2), Black Eyed Peas(blackeye peas. water, sail. calcium chloride and disodium EDTA to preserve color). Chick Peas (chick peas, water, salt, EDTA to promote color retention), Italian Dressing (distilled vinegar. soy bean oil, water, com syrup, salt, onion, red bell pepper, xantham gum, spica and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar, salt, citric acid, CaCI2), Onion, White Vinegar and Garlic Powder
Fajita Mix-Red Pepper, Green Pepper, Spanish Onion {1/4'' Sliced) Item #SAL4, 5 lb poly bag
Tex Mex Sliced Vegetable Blend, Item #TMEX Red Pepper, Green Pepper, Spanish Onion {1/4'' Sliced) 5 lb poly bag
Amy's Brand Pizza Pesto Made with Organic Vegetables & Basil in 7 oz; ; 13.5 oz; Sku# 42272-00104 Product is processed and packaged by Amys Kitchen, White City, Oregon
Trader Giotto brand Pesto Pizza in 13.5 oz; SKU# 00539937; Product is processed and packaged by Amy's Kitchen, White City, Oregon
Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:'' T&T SWAI ROSE ROLL(Pangasius hypophtalmus)***FARM-RAISED PRODUCT OF VIETNAM***''. Packaged in paper box carton.
Dippin' Stix Sliced Apples & Caramel with Peanuts
Apple Slices & Fat Free Caramel Dip contained in the Armour Active Packs Cheese Pizza Lunch Kit
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Yogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of granola, packaged in a clear container, and granola is in the inner container. The product is labeled in part: '***YOGURT PARFAIT STRAWBERRY***9oz (225g)***Distributed by PACIFIC COAST FRUIT CO***Portland, OR 97267***
Aussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Canon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility
Organic Pinenuts. 5lb bag: Organic Pine nuts packed into plastic bag with a twist tie with a White stick on label with hand written product description. 27.5lb bag: Organic Pine nuts inside of a plastic bag with a white stick on label with typed product description.
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Pico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads in part:'' REAL MEX FOODS ITEM # 15102 ''MILD'' PICO DE GALLO*** PACK SIZE: 5/2 LBS. NET WEIGHT: 10 LBS Real Mex Foods 3305 Vernon Ave. Vernon, Ca 90058***''.
Cheese and red onion enchilada, 2 oz packaged in 240/2oz case, net weight 30 lbs. Product labeling reads in part:'' REAL MEX FOODS Item # 14800 CHEESE & RED ONION ENCHILADA***KEEP REFRIGERATED*** PACK SIZE: 240/2 OZ. NET WEIGHT:30.00 LBS Real Mex Foods 3305 E. Vernon Ave. Vernon, Ca 90058.***''
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Tanimura & Antle Romaine Lettuce (Laitue Romaine) in plastic bag Wrapped Single Head Romaine marked Field Packed for Freshness.. Distributed by Tanimura & Antle, Salinas, CA.
SunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.).
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
Dole Italian Blend; Romaine, Radicchio; 10 oz plastic bag (283g); UPC:7143000819. Dole, Monterey, CA 93942.
Naturally Fresh Salad Toppings, Roasted & Glazed Pecan Pieces, Net weight 3.5 oz, Distributed by: Naturally Fresh, Atlanta, GA
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Frozen tiny oyster meat I.Q.F. , 40x8oz (20lbs/case);
Frozen Large Oyster meat I.Q.F, 6x5lbs.(20lbs)
Frozen Half Shell Oyster meat I.Q.F, 5x4lbs (144pieces/case).

Code Info
Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
All lots of the Eon (Product Code 65-3716)
All lots of Eon Mini (Product Code 65-3788)
Size: 8 oz. UPC: 7 71163 00005 2 Lot #: L410805 plus 4-digit time code Date Code: Best Before 12AU15
Best By Date August 11th August 26th 2012 UPC code 7-08820-85464-2
Best By Date August 11th August 26th 2012 UPC code 7-08820-85468-0
Best By Date August 11th August 26th 2012 UPC code 7-08820-85353-9
All products that has a plant code of ''38-25''.
all products that has a plant code of ''38-25''.
all products with a plant code of ''38-25''.
None identified (Product shipped between June 23rd and July 27th).
Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
Packaging is labeled with a best buy date of 1 year from repackaging date.
Produced on: Between 7/18/12, and 7/25/12
Produced on: Between 07/18/12 and 7/25/12
Produced On: Between 7/18/12, and 7/25/12
Produced on: Between 7/18/12 and 7/25/12
7 oz: Best Before July24 2012; Lot Code: 30-G242, sku# 42272-00197; 13.5 oz Best by 7/17/12, Lot No. 30-G172; 383 grams, best by 7/17/12, Lot No. 30-1992AK and best by 7/18/12, Lot No. 30-2002AK (French labeling)
Best Before July 17, 2012 and July 18, 2012; Lot Code: 30-1992AK and 30-2002AK
For IQF 15 lbs bulk, lot numbers: 070S8 070C9 071C6 071C7 071C5 071S5 071C8 072S7 072S9 072S8 072S4 072S5; For 11lbsx2 cartons: 054S; For 2lbsx 5 cartons: 070C3 and 070C4; For 15 lbs cartons: 070S7
USE BY dates 01SEP2012, 02SEP2012, and 03SEP2012
Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
Product Code 5883730 lot number REVK0125.
Model Number 392-09-706, Lot Number 59602519
Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
Models MRT-1503 and MRT-1504 '' MRT-1503 systems with software V9.01 *R240 through V9.20*R242 '' MRT-1504 systems with software V9.21 *R24
Lot 40034 and all organic pinenuts distributed between March 22, 2012 to August 14, 2012
product codes 2M8170 and 2M8170R, all serial numbers
product codes 2M8171 and 2M8171R, all serial numbers
May have a best buy date of 8/19/12 and available at retail locations from August 2 to 19, 2012.
Net wt. 6 ounce (plastic bag) and 10 ounce (rigid plastic container).
Product codes: 20390 (US), 20391 (EMEA and WW), 20394 (Canada), and 20690 (Korea).
Code number 0049N2202008. Best by Date of August 20, 2012.

Product Quantity
7cs-84/8 oz. packages, or a total of 588/8 oz
8,412 units for all products under recall
837 kits (96 assays per kit), total of 80,352 individual assays
580 cases (9 whole cantaloupes per case). Additional188,902 cantaloupes.
2095 cases: 1969 cases in US, 126 cases in Canada - 12 to 18 heads per case.

Reason for Recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor for whom the arm appearance was not acceptable was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor taking the medication Propecia, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, collected using apheresis kits with small detected leaks, was distributed.
Blood products, collected from a donor with a history of Hepatitis A, were distributed
Distribution of a product that did not meet specifications. (labeling error)
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
Blood products, which were labeled with an incorrect volume, were distributed.
Blood products, collected from a donor whose physical was rescheduled as a sample only, were distributed.
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reconstructed images for the data acquired by Go scanning. This phenomenon is due to a problem in the image reconstruction software. It should be noted that this error occurs, the error does not occur for in-scan reconstructed images or images obtained by selecting and reconstructing the acquired raw data for each scan individually after scanning is completed. 2. It has been found that when scanning is performed while the tube current is modulated (Sure Exposure 3D), a transmission of the modulation data to X-ray control section may fail due to a hardware problem, and an error occurs at the time of scan setup as a result. If this error occurs at the time of scan setup as a result. If this error occurs, the error message shown in the figure on the right is displayed on the monitor and the eXam Plan is interrupted. In addition, if this error occurs in an eXam Plan in which Sure Exposure 3D is selected as the actual scan for SureStart, the right error message is displayed after monitoring scan. Monitoring scan therefore cannot be switched to the actual scan and the eXam Plan is interrupted as a result. It should be noted that this error does not occur when the tube current is modulated in ECG synchronization.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
On 8/13/12, Highline Mushrooms, of Ontario Canada, voluntarily recalled lots of sliced, white mushrooms that may be contaminated with Listeria monocytogenes. Ciolino Wholesale Produce, Inc. received a shipment of the mushrooms and initiated their own voluntary recall upon receiving notice from Highline Mushrooms.
As of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.
Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.
Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared Brazil nuts.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and peanut oil.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and wheat.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant and for undeclared color Yellow 5.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #6, and soy (lecithin).
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared red 40, Blue 1, and Blue 2.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #5.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared wheat.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because it may contain undeclared peanuts in contains statement. Milk and peanuts listed in ingredient deck, however, only milk listed in contains statement.
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow 5, Yellow 6, Blue 1, Blue 2 and or soy (lecithin).
Cass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant.
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions ''Regions of Interest'', ''Pixel Lens'', ''Edge Enhancement'' and ''Histograms''.
There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Product was found to be contaminated with Listeria monocytogenes.
The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.
The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
New York State Department of Agriculture sampled the product and found undeclared colors in Jakes Candy Spice Drops. The firm was notified on 4/19/2012 via letter from New York. FDA conducted follow up and associated inspections on 6/29/12, 7/26/12 and 7/27/12 and determined the labels continued to have the undeclared colors, including FD & C Red 40, Yellow 6, Blue1 and Red 3.
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Products contain recalled Gill's Onions due to Listeria monocytogenes
Product contains undeclared peanut in the ingredient statement (Peanuts were found in pinenuts).
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
The product was recalled because nitrofuran residue was detected.
Reichel Foods is recalling these products because the sliced apples have the potential to be contaminated with Listeria monocytogenes.
It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However, subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database, but will not update under the OnePlace tab, and thus, will not provide current vital signs on the OnePlace display, unless the OnePlace tab is manually refreshed by the user.
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Microbial Contamination of Non Sterile Product; mold
Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.
The Yogurt Parfait Strawberry contains coconut, but the label does not declare coconut.
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as ''Free'' mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.
The status display in the sequence queue window may not change from ''Current'' to ''Done''.
Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.
Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
Organic Pinenuts are recalled due to potential contamination of peanuts or traces of peanuts.
Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches .01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter.
The firm recalled because products manufactured used the cilantro recalled by their supplier has the potential to be contaminated with Salmonella.
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed ''5 mL x 50,'' instead of ''10 mL x 50,''
FDA was notified by CFIA of a positive result for E-cole O157:H7 in Romaine Lettuce with the brand name of Tanimura & Antle, Salinas, CA.
SunFresh Natural 6 ounce Fruit & Nut product label does not list sulfites and FD&C Yellow #6 ingredients.
The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
USDA MDP program collected samples of finished product Dole Italian Blend and had positive sample results for Listeria Monocytogenes.
Product contains undeclared allergen, almonds.
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Interstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.