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U.S. Department of Health and Human Services

Enforcement Report - Week of February 20, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons) Lot #MA012304. Class I Altiza is recalling Malichita brand cucumbers because they may be contaminated with Salmonella. Altiza Inc.
Biologics Source Plasma 06DTXA8078;06DTXA8396;06DTXA9188;06DTXB1558;06DTXB2400;06DTXB3165;06DTXC1480;06DTXC1932;06DTXC2667;06DTXC2894;06DTXC3340;06DTXC4214;06DTXC4645;06DTXC4859;06DTXC5314;;06DTXC5567;06DTXC5928;06DTXC6248;06DTXC6528;06DTXC6853;06DTXC7162;06DTXC7518;06DTXC7742;06DTXC8149;06DTXC8428;06DTXC8974;06DTXC9161;06DTXC9715;06DTXC9887;06DTXD0443;06DTXD0658;06DTXD1174;06DTXD1404;06DTXD2067;06DTXD2598;06DTXD2753;06DTXD3043;06DTXD3244;06DTXA3551;06DTXA3989;06DTXA1898;06DTXA4370;06DTXD3679;06DTXD3896;06DTXD4526;06DTXD4986;06DTXD5561;06DTXD5779;07DTXA0133;07DTXA0342;07DTXA4053;07DTXA1332;07DTXA1781;07DTXA1950;07DTXA2300;07DTXA2450;07DTXA2814;07DTXA2996;07DTXA3401;07DTXA3518;07DTXA0549;07DTXA0865. Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells 01GL85672 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01GL85672 Class III Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 011LS38060 Class III Blood product, for which Collection/Aperesis device was not used within acceptable time period, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced collected on 5/31/2005 11GS85442, 11GS85444, 11GS85445, 11GS85446, 11GS85447, 11GS85448, 11GS85449 Class III Blood products, collected using equipment for which quality control was not performed, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 5625333 Class II Donor Screening /incorrect ID used during deferral search, donor previously deferred due to testing. Ogden Medical Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 5625333 Class II Donor Screening /incorrect ID used during deferral search, donor previously deferred due to testing. Ogden Medical Center, Inc.
Biologics Source Plasma 0340806896;0340798958;0340794087;0340787525;0340786632;0340785906;0340784935;0340784713;0340666228;70883794;70878455 Class III Blood products, collected from a donor who was previously deferred by another donor center, were distributed. ZLB Bioplasma, Inc.
Biologics Source Plasma 7020524501;7020522849;7020522124;7020521262;7020520024;7020519462;7020517997;7020517603;7020505336;7020504561;7020503796;7020502939;7020502171;7020500585;7020499830;7020499053;7020498231 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. ZLB Bioplasma, Inc.
Biologics Source Plasma 363016064 Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. International BioResources, LLC
Biologics Red Blood Cells 6731320 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of the Ozarks
Biologics Source Plasma 0340763587;0340762865;;0340765547 Class III Blood products, collected from a donor who was previously deferred due to testing, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 11KF19438 Class II Blood product, collected from a donor who was previously deferred, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 09GP18023(Part A); 09GP18023(Part B) Class II Blood products, which did not meet the acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 6726065 Class II Blood products, collected from a donor taking the medication Accutane, were distributed. Community Blood Center of the Ozarks
Biologics Cryoprecipitated AHF 01LN53192 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Red Blood Cells Leukocytes Reduced 01LN53192 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Plasma Frozen Cryoprecipitated Reduced 01LN53192 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Platelets Pheresis Leukocytes Reduced 011LS44292; 011LS44292; 011LS44292 Class II Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 7571882 Class III Blood product, which was possibly contaminated with penicillium species, was distributed. New York Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced FW15035(Part A); FW15035(Part B) Class III Blood products, for which the quality control testing was incomplete, were distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 115982544 (Part A) ;115982544 (Part B) Class III Blood products, where the blood collection of the products may have been compromised, were distributed. Blood Systems, Inc.
Biologics Blood and Blood Products for Reprocessing 6073325 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells 0301805; 0429177 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 0328053; 0357685; 1336389; W045004001160; W045005025891; W045006037539 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets 0301805; 0429177 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma 0301805; 0328053; 1336389; 0429177; W045004001160 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced 116000858;116000858;116000858 Class II Blood Products, which were contaminated with Corynebacterium species, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 004KK55198 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 004KK55198 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596; 033GM59812 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 033GM57596;033GM55654 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 033GM57596;033GW54331;033GM55654 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 033GM35609 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 033GM37984 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 033FP63417P1;033FP63417P2 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 033FE00104B2;033FE00104B1 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 033GM35609 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 037307127 Class III Blood product, which exceeded time allowed for storage and shipping temperatures, was distributed. Talecris Plasma Resources, Inc.
Devices Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Catalog number: 101 and Serial Numbers: 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117,1124,1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347, 1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660,  ...
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Class II Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications. Terumo Cardiovascular Systems Corporation
Food HEB Deli General Joes Chicken Entree, UPC 0026966900000; HEB Deli HE Bowl General Joes Chicken, UPC 0026967400000; HEB Deli General Joe's Chicken Retail Pack, UPC 0026520900000; HEB Deli General Joes Chicken UPC 0026703700000 All product sold prior to 05/03/12. Class I The product has the potential to be contaminated with salmonella. He Butt Grocery Company
Food HEB Deli Lemon Grass Chicken Entree UPC 0026967100000; HEB Deli HE Bowl Lemon Grass Chicken UPC 0026967600000; HEB Deli Lemon Grass Chicken Retail Pack UPC 0026521800000; HEB Deli Lemon Grass Chicken UPC 0026705200000 All product sold prior to 05/03/12. Class I The product has the potential to be contaminated with salmonella. He Butt Grocery Company
Food HEB Deli Sesame Chicken Entree UPC 0026960600000; HEB Deli HE Bowl Sesame Chicken UPC 0026967700000; HEB Deli Sesame Chicken Retail Pack UPC 0026521900000; HEB Deli Sesame Chicken UPC 0026704500000 All product sold prior to 05/03/12. Class I The product has the potential to be contaminated with salmonella. He Butt Grocery Company
Food HEB Deli Sweet and Sour Chicken Entree UPC 0026967200000; HEB Deli HE Bowl Sweet and Sour Chicken UPC 0026967800000; HEB Deli Sweet and Sour Chicken UPC 0026705000000 All product sold prior to 05/03/12. Class I The product has the potential to be contaminated with salmonella. He Butt Grocery Company
Devices Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet & RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935. Class II The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter to tear. Aesculap, Inc.
Devices Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675 Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011 Class II Expired product was shipped to two customers. Bacterin International, Inc.
Devices GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA  ...
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Class II GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient monitor continues to monitor parameters and alarms as a stand-alone bedside with no issues. GE Healthcare, LLC
Devices GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. Mfg Lot or Serial # SE507460028GA SE507460050GA SE507460053GA SE507460054GA SE507460055GA SE507460056GA SE507460057GA SE507460058GA SE507460059GA SE507460060GA SE507460061GA SE507460062GA SE507460063GA SE507460066GA SE507460067GA SE507480070GA SE507480071GA SE507480073GA SE507480075GA SE507480077GA SE507480078GA SE507480079GA SE507480080GA SE507480082GA SE507480083GA SE507480084GA SE507480085GA SE507480091GA SE507480098GA SE507480099GA SE507480101GA SE507480102GA SE507480105GA SE507480108GA SE507480109GA SE507480110GA SE507480115GA SE507480118GA SE507480120GA SE507480123GA SE507480124GA SE507480125GA SE507480135GA SE507480139GA SE507480148GA  ...
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Class II GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped. GE Healthcare, LLC
Veterinary Regular Chicken 50# Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage Products, Animal Fat procession with DHA, etc 8/6/2012 Class III During an FDA sample collection, the firms 50# Regular Chicken Feed was found to contain mammalian protein. The label does not contain the warning statement. Cohoons Elevator Inc.
Devices GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599 Class I Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. GE Healthcare, LLC
Devices Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Model M1139612 Class I Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. GE Healthcare, LLC
Devices The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998. Class I Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. Lumenis Limited
Drugs Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9 Lot #308198, Expiration Date is 03/2014 Class II Failed Dissolution Test Requirements Upsher Smith Laboratories, Inc.
Devices Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2 x 2 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2 x 3.5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode. All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Class II Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. NAImco Inc dba Richmar Inc
Devices Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2 x 2 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2 Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2 x 3.5 Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25 Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2 x 2.25 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode. All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Class II Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. NAImco Inc dba Richmar Inc
Devices Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode. All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Class II Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. NAImco Inc dba Richmar Inc
Devices Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2 x 2 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2 x 3.5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3 x 5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2 x 4 Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode. All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Class II Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. NAImco Inc dba Richmar Inc
Veterinary Lone Star 22-10-.5 Instant Medicated Calf Milk Replacer 25lb bag, manufactured for Texas Farm Products Company, Nacogdoches, Texas 75963 All product manufactured between January 1, 2012 and December 18, 2012 (lot codes: 202802, 202301, 200902-05, 203204, 203303-05, 206601-02, 206501-05, 209001-04, 211701-03, 215301-05, 219501-05, 224304-06, 223401-03, 229202-04, 234801-05) Class II Category II drug NeoOxy 100/100 MR used in milk replacer was expired as of December 2011. Dairy Manufacturers, Inc
Food "ESTRELLA***Empanadillas de Pizza" (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***". No code Class II Undeclared wheat and undeclared milk as the source of cheese. Suadel Food Products, Inc.
Food "Estrella Food Products, Inc***Pastelillos de Queso (Cheese Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***". No code Class II Casein is listed as a sub-ingredient of cheese, but common name "milk" is not declared in the list of ingredients and/or "Contains" statement. Suadel Food Products, Inc.
Food "Estrella Food Products, Inc***Pastelillos de Pizza (Pizza Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***". No code Class II Casein is listed as a sub-ingredient of cheese, but common name "milk" is not declared in the list of ingredients and/or "Contains" statement. Suadel Food Products, Inc.
Food "Estrella Food Products, Inc***Empanadillas Sabor a Carne(Meat flavorTurnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***". No code Class I Wheat and soy is not declared. Suadel Food Products, Inc.
Food "Estrella Food Products, Inc***Plantillas Para Pastelillos, tacos, Empanadillas, etc. (Yellow dough shells)***12 units, and 20 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***". No code Class II Undeclared Yellow #6 and soy Suadel Food Products, Inc.
Food "Estrella Food Products, Inc***Pastelillos de Guayaba (Guava Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***". No code Class III Undeclared Red #40 Suadel Food Products, Inc.
Devices Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. Table model 5855, sub assembly 5855-901 Orthopedic Table Spar manufactured between 1996 and 2007. Class II Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top. Mizuho OSI
Devices Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. Lot # Range: 208228-214385, 707916-708108 (29 lots). Class II Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis. Quidel Corporation
Devices Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS "Gyrocam DNV Camera System, Serial Numbers: 137, 138, 141, 142, 143, 144, 145, 148, 150, 151, 152, 158, 159, 160, 164, 165, 170, 172, 173, 174, 175, 177; Gyrocam DS Camera System, Serial Numbers: 134, 140, 147, 153, 169, 181; Gyrocam TS Camera System, Serial Numbers: 132, 146, 149, 171, 502. " Class II These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system. Lockheed Martin Gyrocam Systems, Inc.
Drugs Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01. Class II Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection. Hospira Inc.
Devices Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: 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. Serial Numbers: CN14800428, CN14800429, CN14800430, CN14800431, CN14800432, CN14800433, CN14800434, CN14800435, CN14800436, CN14800437, CN14800438, CN14800439, CN14800440, CN14800756, CN14800763, CN14800764, CN14800765, CN14800772, CN14800773, CN14800822, CN14800823, CN14800824, CN14800979, CN14801332, CN21201423, CN21201625, CN21202029, CN21202030, CN21202031, CN21202032, CN21202033, CN21202034, CN21202234, CN21202239, CN21202240, CN21202241, CN21202242, CN21202243, CN21202317, CN21202320, CN21202347, CN21202348, CN21202349, CN21202350, CN21202351, CN21202376, CN21202435, CN21202606,  ...
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Class II VS2+ screen may lock up and stop monitoring during patient use Philips Healthcare Inc.
Drugs Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01. Lot #: 69001A Class III Subpotent Drug: Test results for assay were confirmed Out Of Specification (OOS) at 92.8% (specification of 97.0 - 103.0%). West-ward Pharmaceutical Corp.
Devices Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position. Serial Numbers: 36977-1210, 37194-0312, 37455-1111, 37606-0312, 36988-1210, 37220-0511, 37484-1111, 37614-0312, 36999-1210, 37234-0511, 37495-1211, 37628-0312, 37000-1210, 37273-0611, 37497-0711, 37632-0312, 37003-1210, 37305-0711, 37515-1211, 37633-0312, 37014-1210, 37307-0711, 37520-1211, 37636-0312, 37061-0211, 37333-0711, 37521-1211, 37637-0411, 37067-0111, 37348-0811, 37523-1211, 37675-0412, 37094-0211, 37374-0911, 37537-0112, 37681-0412, 37114-0211, 37393-0911, 37555-0112, 37286-0511, 37122-0211, 37394-0911, 37576-0212, 37296-0611, 37137-0311, 37440-1011, 37584-0212, 37141-0311,  ...
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Class II The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW). CHENICA INC.
Devices Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume. Class II Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals. Viterion TeleHealthcare Llc
Devices Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Bayer HealthCare LLC Tarrytown, New York USA. Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume. Class II The company received complaints reporting that "HI" readings on certain blood glucose meters were not transmitting from the patient end through Viterion V100 telehealth monitors to healthcare professionals on the other end, who monitor the patient. A "HI" reading indicates that the blood glucose result obtained was beyond the measurable range of the meter. Subsequent investigation confirmed that the Viterion V100, V100-BGM and V500 telehealth monitors do not transmit both "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, as well as from Roche's Accu-Chek Advantage 03 and 04 meters. Viterion TeleHealthcare Llc
Devices Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) --- Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Viterion TeleHealthcare LLC Tarrytown, New York USA. Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. All units are affected. Serial Numbers A3303HA000201, A3303HA000202, A3303HA000203, A3303HA000204, A3303HA000205, A3304HA000206, A3304HA000207, A3304HA000208, A3304HA000209, A3304HA000210, A3305HA000211, A3305HA000212, A3305HA000213, A3305HA000214, A3305HA000215, A3306HA000216, A3306HA000217, A3306HA000218, A3306HA000219, A3306HA000220, A3310HA000221, A3310HA000222, A3310HA000223, A3310HA000224, A3310HA000225, A3404HA000226, A3404HA000227, A3404HA000228, A3404HA000229, A3404HA000230, A3404HA000231, A3404HA000232, A3404HA000233, A3404HA000234, A3404HA000235, A3404HA000236, A3404HA000237, A3404HA000238, A3404HA000239, A3404HA000240, A3404HA000241, A3404HA000242, A3404HA000243, A3404HA000244,  ...
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Class II The company received complaints reporting that "HI" readings on certain blood glucose meters were not transmitting from the patient end through Viterion V100 telehealth monitors to healthcare professionals on the other end, who monitor the patient. A "HI" reading indicates that the blood glucose result obtained was beyond the measurable range of the meter. Subsequent investigation confirmed that the Viterion V100, V100-BGM and V500 telehealth monitors do not transmit both "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, as well as from Roche's Accu-Chek Advantage 03 and 04 meters. Viterion TeleHealthcare Llc
Devices Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices. "Part No Serial No 300BF-PA00002 EH-17000037 300BF-PA00002 EH-17000032 300BF-PA00002 EH-17000033 300BF-PA00002 EH-25000099 300BF-PA00002 EH-18000043 300BF-PA00003 EH-1A000072 300BF-PA00002 EH-22000088 300BF-PA00003 EH-1A000073 300BF-PA00002 EH-12000060 300BF-PA00002 EH-17000038 300BF-PA00003 EH-21000077 300BF-PA00002 EH-18000058 300BF-PA00002 EH-23000096 300BF-PA00003 EH-19000059 300BF-PA00003 EH-19000060 300BF-PA00002 EH-18000051 300BF-PA00002 EH-12000054 300BF-PA00002 EH-16000029 300BF-PA00002 EH-11000052 300BF-PA00002 EH-17000039 300BF-PA00003 EH-1A000064 300BF-PA00002 EH-18000050 300BF-PA00003 EH-13000078 300BF-PA00003 EH-13000085 300BF-PA00002 EH-18000053 300BF-PA00002 EH-17000036 300BF-PA00002 EH-17000031 300BF-PA00003 EH-17000040 300BF-PA00002 EH-18000054 300BF-PA00002 EH-1A000069 300BF-PA00002 EH-12000062 300BF-PA00002 EH-21000076 115-006908-04 Software Kit 300BF-PA00003 EH-13000083 300BF-PA00003 EH-13000084 300BF-PA00003 EH-22000087 300BF-PA00002 EH-18000056 300BF-PA00002 EH-17000035 300BF-PA00002 EH-18000048 300BF-PA00002 EH-18000052 300BF-PA00003 EH-21000081 300BF-PA00002 EH-17000030 115-006908-03 Software  ...
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Class II Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices St. Jude Medical, AGA Medical corporation, AMPLATZER® TorqVue® FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums. all batches Class I The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. St Jude Medical Inc
Food Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated. Product of Guatemala UPC 7 16519 13004 Distributed by Mann Packing, Salinas, CA. Best by Date: January 22, 2013. Class III California Department of Food and Agriculture randomly sampled Sunny Shores Mann's snap peas and found them to contain 0.278 and 0.195 ppm of Carbendazim. Carbendazim is a pesticide that is not allowed in the US but is approved for use in the EU> Mann Packing Co Inc
Devices Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis. Lot 12BR08009 Class II There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. Fresenius Medical Care Holdings, Inc.
Devices BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. Affected product will be identified by date of manufacture from January 2010 through October 2012. Class II The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. Breg Inc
Devices BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410. Local anesthetic effect. Affected product will be identified by date of manufacture from January 2010 through October 2012 Class II The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. Breg Inc
Drugs 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY 10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA 91733, UPC 0 23558 69230 5; e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL 33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 14576 3; h) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, UPC 015127 02305 4, NDC 15127-889-30. Lot #: 2111 and 2114, Exp 04/14 Class II Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing. Lee Pharmaceuticals, Inc
Food Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482 Product Code 93709-30010, Best Before Sep 26, 2013. Class II Firm received complaints for on four (4) products which may contain glass or plastic fragments. Pamela's Products, Inc.
Food Pamela's Chocolate Chunk Cookie Mix; Gluten Free, Wheat Free, Non Dairy 13.9 oz. package. UPC 93709-30050 Pamela's Products, Ukiah, CA 95482 Product Code 93709-30050, Best Before Oct 7, 2013. Class II Firm received complaints for on four (4) products which may contain glass or plastic fragments. Pamela's Products, Inc.
Food Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy 21 oz. package. UPC 93709-30040 Pamela's Products, Ukiah, CA 95482 Product Code 93709-30040, Best Before Sept 11, 2013; Sep 19, 2013 and Oct 4, 2013. Class II Firm received complaints for on four (4) products which may contain glass or plastic fragments. Pamela's Products, Inc.
Food Pamela's Peanut Butter Chocolate Chip Cookies; Gluten Free 5.29 oz. package. UPC 93709-40180 Pamela's Products, Ukiah, CA 95482 Product Code 93709-40180, Best Before Apr 14, 2013. Class II Firm received complaints for on four (4) products which may contain glass or plastic fragments. Pamela's Products, Inc.
Devices GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA  ...
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Class II GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device. GE Healthcare, LLC
Biologics Rho(D) Immune Globulin (Human) RVP187D1 Class III RhoGAM syringes, with lack of assurance of proper temperature monitoring during shipment, were distributed. Ortho Clinical Diagnostics Inc
Food ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Raw Lot #121203 Class I Hoop Nuts is recalling Pistachios due to Salmonella. Hoop Nuts LLC DBA Christophers Nut Co
Food ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Dry Roasted Lot #1-121213 Class I Hoop Nuts is recalling Pistachios due to Salmonella. Hoop Nuts LLC DBA Christophers Nut Co
Devices Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. Part No. 5012, Lot No. B7PPC Class III Incorrect packaging of regular set and fast set cartridges. Ultradent Products, Inc.
Devices Ultradent Product, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics. Lot No. B7DS3 Class III Incorrect packaging of regular set and fast set cartridges. Ultradent Products, Inc.
Drugs Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14. Lot #: RB93911, Exp 07/14 Class III Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. Ranbaxy Inc.
Drugs Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA. Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13 Class III Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. Ranbaxy Inc.
Food Labeled in part: "All Natural Chia ReCharged Stix Mix***Chia Seed Sticks***Net Wt. 5oz", UPC Code: 0 94184 01014 6 Lot #'s: 052112, 060512, 071712, 080212, and 081612; Best Before dates 01/20/13 to 04/17/13 Class I Undeclared peanuts. Tropical Nut & Fruit Co., Inc.
Food CULINARY Creations (brand) CHEESY BROCCOLI SOUP, 3F3080, CONTAINS: 20/2 LB. CHUBS, NET WT. 40 LBS. 91816 KG), DIVERSIFIED FOODS AND SEASONINGS, INC, 1115 N. CAUSEWAY BLVD. STE.200, MANDEVILLE, LA 70471 1-800-835-3374, FOR INSTITUTIONAL USE ONLY, UPC 00732628330803 100512 Class I The firm received a complaint of a consumer finding shrimp in Broccoli Cheese Soup. Diversified Foods & Seasonings, Inc.
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