Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected using expired blood collection sets, were distributed.
Blood Products, which were collected in an expired collection bag, were distributed.
Plasma Frozen within 24 hrs After Phlebotomy
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who did not have a complete physical examination, were distributed
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
The American National Red Cross - Southern Region
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Washed
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 with a history of high risk behaviors, were distributed.
Blood products, which were collected from a donor in which donor suitability  was not adequately determined, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed.
American Red Cross Blood Services Carolinas Region
Blood products, which did not meet the acceptable product specifications, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Donor Screening/Donor did not meet acceptance criteria
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630   Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010'' instead of 0.020''. This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
Product was distributed within the US to IL, NJ, and NY.
Stewart's Diet Orange N' Cream Soda, 12oz glass bottles
Incorrectly placed ingredient label for non-diet beverage on bottles of diet beverage.  The ingredient label incorrectly provided the ingredients for regular Stewart's Orange N' Cream Soda.  The front label on the glass bottles and the 4 carrier secondary package correctly identified the product as Stewart's Diet Orange N' Cream Soda.
Worldwide distribution: USA (nationwide) and country of: Japan.
Zilver 518 Vascular Self Expanding Stent   The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
Cook Ireland received a product complaint from Japan on December 22nd, 2011.  The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub.  After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35-80-10-30) rather than a 5 French size.
Blood product, collected from a  donor, whose suitability to donate was not adequately determined, was distributed.
AL, FL, GA, IA, KY, MD, MI, NY, NC, OH, PA, SC, TN, VA, Canada, Colombia, Japan and the Russian Federation.
Diamond Pet Foods, Naturals Lamb Meal & Rice Formula for Adult Dogs, Packed in 6 lb (UPC: 0 7419860995 6), 20 lb (UPC 0 7419860816 4), and 40 lb (UPC 0 7419860817 1) bags, Proudly made by Diamond Pet Food, Meta, Missouri.
Product Code: DLR0101D3XALW, Best Before 04 Jan 2013 (6 lb bag); DLR0101C31XMF, Best Before 03 Jan 2013 (20 lb bag); DLR0101C31XMF, Best Before 03 Jan 3013; DLR0101C31XAG, Best Before 03 Jan 2013 and DLR0101D32XMS, Best Before 04 Jan 2013 (40 lb bags).
Chicken Soup for the Dog Lovers Soul, Adult Dog Light Formula, Brand Dog Food, Net Wt 6 lb (UPC Code: 0 7419860795 2) and 35 lbs (15.87kg) bags (UPC Code: 0 7419860981 0), Proudly made by Diamond Pet Food, Meta, Missouri.
Code: Production Code: CLF0102B31XCW, Best By Date: 27/JAN/2013, CLF0102B31XCW, Best By Date: 28/JAN/2013 and CLF0102B32XWR, Best By Date: 28/JAN/2013 (35 lb bags). Product Code: CLF0102B3XALW, Best by Date: 28/JAN/2013 (6 lb bags).
2,444/35 lb bags and 251 6/6 lb bags and 49 6/8 lb bags
Diamond Pet Foods, Puppy, Net Wt 6 oz samples (UPC Code: 0 7419800200 9), 8 lb (UPC Code: 0 7419800208 5), 20 lb (UPC Code: 0 7419800220 7) and 40 lb bags (UPC Code: 0 7419800240 5), Proudly made by Diamond Pet Food, Meta, Missouri.
Code: Production Code: DPP0401 (6 oz samples); DPP0401B2XALW, Best By Date: 7Apr/2013 (8 lb bags); DPP0101C31XRB, Best By Date: 11/Jan/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401B22XJW, Best By Date: 6/Aprl/2013 (20 lb bags) and DPP040B2XDJ, Best By Date: 7/Apr/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401A21XAW, Best By Date: 6/Apr/2013 and DPP0401B22XJW, Best By Date: 6/Apr/2013.
Distribution was made to IL, CO, TX, PA, FL, and NV.  Foreign distribution was made to Canada.
Purina Veterinary Diets OM Overweight Management Feline Formula, packaged in 5.5-oz. cans, UPC 38100-13810, for prescription and sale only by veterinarians.   The firm name on the label is Nestle Purina Petcare Co., St. Louis, MO.
The product is deficient in thiamine (Vitamin B1)
USA ( nationwide)  WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011.   There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same.    The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.
4 oz translucent plastic bottle of - One Black Tattoo Ink.  Primary Display Panel - front of squeeze bottle is labeled as follows:  ''***one***Ingredients:  C.I.77226; C.I.74160;***proprietary; glycerin; distilled water; alcohol Net 4 fl oz. (118.4)***Warning:  This product is pure pigment.  application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied.  Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***''         The Secondary Display Panel - back of squeeze bottle is labeled as follows:  ''***Lot#***EXP***'' or with ''***Lot#***EXP*** Warning:  This product is pure pigment.  application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied.  Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***''
One Black Tattoo Ink 4oz. translucent plastic bottle. Lot #'s 20110621, 20110901, 20111014, 21120104, and 20120223.
On 11/15/2011, Kingpin Tattoo Supply, Inc. initiated a recall for the product ONE Black Tattoo Ink (4 oz. bottle) due to lab test results finding traces of a soil based bacillus type bacteria in the ink.
Farmers markets in Washington State and retailers in Washington and Oregon.
Flavored cheddar cheese, vacuum packed in weights ranging from 0.25-0.50 pounds, labeled and batch coded by firm.  Cheese labeled in part:  ''Medium Cheddar Red Pepper with Onion & Garlic Pasteurized whole milk, salt, culture, vegetable rennet, spices.  r-BST free.***GOLDEN GLEN CREAMERY 15098 Field Road  Bow, WA 98232***887''
Product may be contaminated with Listeria monocytogenes.
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***   BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.
Leakage in Cepheid SmartCycler reaction tubes.
BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***   BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.         .
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***   BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests   2-3 labeled  in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***   BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests  labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***.   The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.
Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
Nationwide Distribution-including the states of NJ, NY, and PA.
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA.      The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
510 k K083746   Catalog Number 1001-0320 - 22 test kits  Catalog 1001-0322 - 12 test kits
370 (12 tests per kit) ;2800 kits (22 tests per kit)
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Poly stat Flu A &  B Test Manufactured for   Polymedco  510 Furnace Dock Road  Cortlandt Manor, NY 10567  Tel 800-431-2123         914-739-5400  Fax 914-739-5890.      The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
510 k K083746   Catalog Number FLU22  Lot numbers 441A11, 441C11
Status Flu A + B Test Manufactured by   Princeton Bio Meditech Corporation  Monmouth Junction, NJ 08852 USA.    The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
510 k K083746   Catalog Number 36022  Lot numbers 441H11  90 kits (22 tests per kit)
Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Cracks can arise on the welded seam on the rear joint.
Trader Jose's, Mild Salsa, 16 ounce (1 lb) 454g), in clear rigid plastic containers with snap on lids.
Products contain an ingredient (onions) that were found to be contaminated with Listeria monocytogenes.
Trader Joe's, Balela (A savory Middle Eastern salad with chickpeas, black beans and tomatoes). 8 ounces (227g). in clear rigid plastic containers with snap on lids.
Distributed to Targets and Walmarts in 25 states.
CLIF Bar Brand Coconut Chocolate Chip CLIF Bars, 6-pack boxes, UPC: 7-22252-66030-5   Product is manufactured by  Harlan Bakeries in Indianapolis, IN.
Best By date: 16MAY13G1 on both carton and individual bars contained within.
The product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes.
CLIF Bar Brand White Chocolate Macadamia CLIF Bar, 2.4 oz (68g), Individually wrapped bars   Product is manufactured by  Harlan Bakeries in Indianapolis, IN.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers:   2 Pack REF 07907174 (110312)   6 Pack REF 07293184 (110313).    Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for  for BNP and TSH3 Ultra assays
USA ( nationwide ) including the states of  AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.   This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.
Version VA11B and all previously released versions.
When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification.  QC status may not be flagged appropriately.  If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expected.  The problem is encountered under the following conditions:  1 - The QC package within the syngo(R) system is being used to evaluate QC; 2 - The syngo(R) system is configured with Multi-Rule QC, and the Multi-level option is selected without following the instructions on page 2 of the recall letter.
Distribution was made to CA, CO, DE, FL, ID, IL, MD, MO, NJ, NM, NY, OH, OR, TX, VA, and WA.
Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788.  The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO.
The product is labeled as gluten free but contains wheat, which is listed in the ingredient statement
Worldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY.  Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer   The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Software: Cat. 6133-30-3, Version 5.4.3.
Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database.
Pine nuts, raw and shelled. Packaged in plastic bag. Labeling reads in part:''Jaffe Bros.***Organically Grown Raw, Shelled Pine Nuts This product was packaged on shared equipment that also processes Peanuts***Distributed by Jaffe Bros., Inc. P.O.Box 636 Valley Center, CA 92082***''.
Recall was initiated after firm was informed by their supplier Specialty Commodities that a recall was initiated due to peanuts found in pine nuts.
Nationwide in the US and worldwide to Mexico, Canada.
Apio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line.
Eat Smart Broccoli & Cauliflower, 9x12oz. Item # 10068.  Code Dates: B07208, B08208.
Blueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1
A small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes.  Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars.
Chocolate Chip CLIF Bars, 2.4-oz (68g), individually wrapped, UPC: 7-22252-10090
A small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes. Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars.
Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey,  and United Kingdom.
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490   Product Usage:  The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications.  Specifically, the impeller may not be properly seated on the blower motor shaft.  This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation.
Worldwide Distribution--USA (nationwide) including the states of  AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of  Japan, Peru, and Suriname.
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
AL, AZ, ALR, CA, FL, GA, IL, IN, KS, KY, ME, MS, MO, NE, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WY.
Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5.    Amport Foods Bags:  Amport Foods, Pine Nuts, Net WT 4 0 z (113 g), 0 71725 70172 5, American Importing Co. Inc, Minneapolis, MN 5514.    Case label: Stock No 50578 12/4 oz, Amport, Pine Nuts Best by: 03-28-13 3621F1, 1 00 71725 70172 2.     Amport Foods Tubs:  Pine Nuts, Net WT 4 0 z (113 g), 0 71725 71180 9, Best BY: 01-10-13    0102 MM1,  Distributed by American Importing Co, INC, Minneapolis, MN 55414.  Tub Case Label: Item #41130 12/4 oz,  Amport Foods, Pine Nuts,   Best by: 01-10-13 0102MM1, 1 00 71725 71180 6.
5,441 cases or 50,100 individual packages
Amport Foods is recalling one lot of pine nuts  because there may be undeclared Peanuts present in the product.
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Newport HT70  and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus.   Product Usage:  The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
intraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles
After extensive testing and investigation, Drucker Labs has determined that an incorrect form of Vitamin B3, Nicotinic Acid, was used in the manufacturing of intraKID Lot 658.  This nutrient may cause a temporary symptom in a small number of consumers.  This symptom, commonly known as Niacin Flush, may include itching, redness, or warmth of the skin.  This typically subsides within 15  20 minutes and has no long-term side effects.
Product was distributed to Winn Dixie Distribution Centers in FL, AL, and LA.
Fresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: ''***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refrigerated***ATLANTIC FISHERIES 8195 NW 67TH ST MIAMI FLORIDA 33166***TEL***FAX 305-594-4301***PACK U.S.A.
Atlantic Fisheries recalled 580 lbs of Mahi Mahi Fillets due to histamine levels over 50 ppm.
Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.
AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com.   The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.
The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system.  The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
US (nationwide) distribution including the states of Ohio and Texas.
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System.   MR imaging.
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
TxRx Knee 15 Coil 3T.   For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.
Product was distributed to the states of Ohio, Pennsylvania, New York, Florida.  There were no US governernment consignees or foreign consignees.
Humphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case.
On 6/5/2012 the firm voluntarily recalled their Candy Kisses due to undeclared milk on the label.
Humphrey Chocolate Drizzle, 5 oz. in a clear plastic bag, UPC Code 8108400009. Bags are packed 12 to a case.
On 6/5/2012 the firm voluntarily recalled their Chocolate Drizzle Popcorn due to undeclared soy lecithin on the label.
Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
Brand name:  RayStation.  Generic name: Treatment Planning System.  Software version and build numbers are 2.5.0.144 and 2.5.1.89.  Product lifetime is 5 years.   RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Software version and build numbers are 2.5.0.144 and 2.5.1.89.  Product lifetime is 5 years.
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimization of segment shapes and allowing for optimization of segment Monitor Units.  As a result, the dose calculation may be incorrect by a factor of 3-6.  The result is always an underestimation of the dose, potentially leading to over-dosage of the patient as MU values are increased to compensate.
Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
Capintec Captus 3000 Thyroid Uptake System    Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087.  Catalog numbers for conversion systems: 5430-0118 and 5430-0119.  Serial numbers for new systems: 901006 through 901394, inclusive.  Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive.  Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26.  (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded.  This system does not have the ability to perform thyroid uptake procedures.)
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual.''  This protocol was a new feature added to Software Revision 1.22 in January 2011.  The error occurs only if the user does NOT measure the residual dose immediately after measuring and administering the does.
Product was distributed in Idaho, Oregon, Washington,
Dole Mushroom,  packaged in a retail package, net wt. 8 oz. The UPC is 0 33383 67600 5.
Code 336.  Packed on Date is PO 11AUG2012. Date code is the ''packed on''date and product has a 10 days shelf life with the pack on date being day one.
Dole 8 oz Sliced Mushrooms, product of Canada, are recalled due to potential contamination of Listeria monocytogenes.
Auburn, WA DC and Spokane, WA DC - distributes to retail stores in OR, WA, ID and MT.
''SAFEWAY farms White Sliced Mushrooms***DISTRIBUTED BY SAFEWAY INC.***PLEASATON, CA***PRODUCT OF CANADA***NET WT 8 OZ (227g)''  UPC 0 21130 28443 6
230 cases from Auburn, WA DC; 50 cases from Spokane, WA DC
Champs 8 oz Sliced White Mushrooms are recalled due to potential contamination of Listeria monocytogenes
AL, AR, FL, GA, IL, IN, KY, LA, MD, MO, MS, NC, OH, PA, SC, TN, TX, VA, WV.
Fresh Express Hearts of Romaine Crunchy and Sweet 100% Hearts of Romaine Lettuce.  10 oz. plastic bag  UPC 71279 26102.  Fresh Express, Salinas, CA.
FDA IEH sample of Fresh Express Hearts of Romaine was found positive for Listeria Monocytogenes.
Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
Siemens Mobilett Mira.   Mobile X-Ray System.
During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system.  During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover.  This may cause the system to continuously move.  In response, Siemens has issued Update Instruction XP038/12/S to replace motor drive handles and circuit board connection cables on all affected Mobilett Mira systems.