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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Helixate FS Antihemophilic Factor (Recombinant), Formulated with Sucrose Lot Nos: 27N1162, 27N10V1, 27N11J1, 27N1501, 27N1511 Class III Antihemophilic Factor (Recombinant), lacking assurance of proper temperature maintenance during storage, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 11FM83788, 11GR40841 Class II Blood products, collected from a donor who lived in the past 3 years in an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 11GR40841 Class II Blood products, collected from a donor who lived in the past 3 years in an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 011FF83187; 11KS06248 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American Red Cross Blood Services
Biologics Platelets Leukocytes Reduced 011FF83187 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 11KS06480; 11KS04232; 11KS00538; 11KS08264; 11FF95935; 11KS05443, 11FF97614 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Platelets Leukocytes Reduced 11KS00538 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Platelets 01KH97931 Class III Blood product, which did not meet acceptable product specifications, was distributed. . American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01LG82416 Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross (The)
Biologics Plasma Frozen 01LG82416 Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross (The)
Biologics Source Plasma 06CWYA9738; 06CWYA9965 Class II Blood products, collected from a donor who had been incarcerated, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 6270545251 Class II Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed. ZLB Bioplasma, Inc.
Biologics Source Plasma 04LWYC8378; 04LWYC9513 Class II Blood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed BioLife Plasma Services L.P.
Biologics Source Plasma WN0111902, WN0112085, WN0112669, WN0112932, WN0113477, WN0113681 Class II Blood products, which were collected from a donor with a history of high risk behavior, were distributed. DCI Biologicals Wilmington, Inc.
Biologics Recovered Plasma 02KH09464 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells 02KH09464 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Source Plasma 0440717563, 0440713681, 0440713230, 0440712609, 0440712115, 0440710890, 0440710577, 0440709938, 0440709495. 0440708625, 0440707487, 0440706213, 0440705292, 0440705095, 0440704240, 0440703417, 0440703076, 0440702360, 0440702102, 0440701110, 0440700493, 0440700055, 0440699483, 0440698945, 0440698119, 0440685470, 0440684962, 0440684518, 0440684078, 0440683544, 0440682994, 0440682511, 0440681992, 0440681513, 0440681001, 0440680529, 0440680040, 0440679541, 0440679061, 0440678588, 0440678117, 0440677686, 0440677207, 0440676730, 0440676310, 0440675859, 0440675386, 0440674933, 0440674463, 0440673998,  ...
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Class II Blood products, collected from a donor who was previously deferred, were distributed. CSL Plasma, Inc
Biologics Red Blood Cells Leukocytes Reduced W045008026209 Class III Blood product, for which the additive solution was not added during manufacturing, was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 02GC02139;02LC96551;02LC92860 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02LP19845 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02LP19845 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Platelets Pooled Leukocytes Reduced 033FL15312 (pool ID: 12845) Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 033FL15336, 033FL15339, 033GL92944, 033GL92945, 033GL92950 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 033FL15292, 033FL15296, 033FL15300, 033FL15301, 033FL15311, 033FL15318, 033FL15319, 033FL15336, 033FN15653, 033FN15659, 033FN15673, 033FN15677, 033FN15679, 033GL92930, 033GL92931, 033GL92933, 033GL92935, 033GL92944 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 033FP67241, 033FP67243, 033FP67244 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Devices PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. Catalog #: PT-Module Class II Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open. Dako North America Inc.
Biologics Source Plasma 4100020301, 4100015238, 4100015014, 10GKTWNC, 10GKTQBZ, 10GKTPDP, 10GKTMVJ, 10GKTLDC, 10GKTJBF, 10GKSZZM, 10GKSSSK, 10GKSRLN, 10GKSQFD, 10GKSNXC, 10GKSNHC, 4100008642, 4100008400, 4100007605, 4100002901, 10GKTRFK, 10GKRNQY, 4100007167, 4100006935, 4100006713, 4100006485, 4100006232, 4100005974, 4100004309, 4100004145, 10GKWQHS, 10GKWJVP, 10GKWKYL, 10GKWKMV, 10GKWJZY, 10GKVFYH, 10GKTBPS, 10CCRKNT, 10CCRJFR, 10CCRHBK, 10CCRGNP, 10CCRFXW, 10CCNZPS, 10CCNYVV, 10CCNXBX, 10CCNWKB, 10CCNVFS, 10CCNTHY, 10CCNSVS, 10GKTKDC, 10GKTHJK,  ...
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Class II Blood products, collected from deferred donors, were distributed. Csl Plasma Inc
Devices Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16400 serial numbers: 1001-1141, 1143-1274,1333 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16405 serial numbers: 1001-1466. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16406 serial numbers: 1001-1004,1007-1055,1057-1310, 1648, 1649, 1657, 1822, and 1823. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16409 serial numbers: 1001-1026 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16410 serial numbers:1001-1034,1036-1061,and 1602-1622. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Biologics MEDITECH Blood Bank Software - Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12. Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12. Class II Blood Bank Software, with a defect or glitch, was distributed. Medical Information Technology, Inc.
Biologics Blood and Blood Products for Reprocessing 020FT37984; Class II Blood products, which were not quarantined after receiving post donation information, were distributed.. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020FT37984; Class II Blood products, which were not quarantined after receiving post donation information, were distributed. American National Red Cross (The)
Drugs Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14 Class III Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution." Stat Rx USA
Biologics Platelets Pheresis Leukocytes Reduced 53LP82140; Class II Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 003FC73672; 003FC73672(2); 003FC73672(3); Class III Blood products, which were exposed to unacceptable temperature during storage, were distributed. The American National Red Cross - Southern Region
Biologics Platelets Pheresis Leukocytes Reduced 003FC73673; 003FC73673(2); 003FC73691; 003FC73691(2); 003FC73692; 003FC73692(2); 003FC73692(3); 003FC73693; 003FC73693(2); 003FC73693(3); Class III Blood products, which were exposed to unacceptable temperature during storage, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 06GH47154; 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 06GH47154; Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross The
Biologics MEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13. Client Server Releases 5.6, 5.65, 6.0, 6.05, 6.06, and 6.13 Class II Blood Bank Software, with a defect or glitch, was distributed. Medical Information Technology, Inc.
Biologics Skin 030539712; 030539982; 030539984; 030511381; 030511382; 030511388; 030511390; 030512003; 030513334; 030513335; 030513336; 030515326; 030515327; 030515777; 030517764; 030517766; 030517769; 030517777; 030518353; 030521200; 030521201; 030521206; 030521207; 030522051; 030522052; 030522056; 030524991; 030524994; 030525179; 030525253; 030529885; 030530134; 030532171; 030520430; 030521191; 030521194; 030533264; 030533266; 030534536; 030534875; 030539711 Class II Skin allografts, lacking assurance of proper temperature maintenance during transportation, were distributed. DCI Donor Services Tissue Services Division
Devices Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection. Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403  ...
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Class II Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. Stryker Howmedica Osteonics Corp.
Food Zatarain's New Orleans Style Beef Flavor Rice Mix, packaged in 6.8 oz boxes, 12 boxes per carton, Box UPC: 7142901001 BEST BY JUN 09 14 H, BEST BY JUL 29 14 H, BEST BY AUG 28 14 H Class II Food product containing wheat was packaged into containers which do not declare wheat on the label. McCormick & Company, Inc.
Food Zatarain's New Orleans Style Chicken Flavor Rice Mix, Item No. Z09705, packaged in 6.3 oz boxes, 12 boxes per carton, Box UPC: 7142901001 BEST BY JUN 10 14 H, BEST BY JUL 30 14 H, BEST BY AUG 31 14 H Class II Food product containing wheat was packaged into containers which do not declare wheat on the label. McCormick & Company, Inc.
Food Zatarain's Chicken/Cheddar Brocolli Mix, Item Number: 900108337, a combination pack containing, 6.3 oz boxes of New Orleans Style Chicken Flavor Rice Mix and Cheddar Broccolli Mix. BEST BY MAY 09 13Z, BEST BY JUN 15 13Z, BEST BY AUG 05 13Z and BEST BY AUG 08 13Z Class II Food product containing wheat was packaged into containers which do not declare wheat on the label. McCormick & Company, Inc.
Biologics LABScreen® Product  LABScreen® Single Antigen HLA Class II Antibody Detection Test -GROUP 1 Product Number: LS2A01 510(K) Number : BK 030069 Product Code : MZI PMA Number : N/A Preamendment : No Product Number: LS2A01 Lot Numbers : 003 - 008 Expiration Date: Lot 003 11/2007 Lot 004 09/2008 Lot 005 10/2009 Lot 006 05/2010 Lot 007 04/2012 Lot 008 04/2013 Product Insert Number: LS_LSCN-PI-EN-00, Rev. 17 Class III LABScreen HLA Class II Antibody Detection Test, associated with false reactions with the DP20 antigen, was distributed. One Lambda Inc
Biologics Red Blood Cells W036812496391 Class III Blood product, collected from a donor whose arm inspection prior to collection was not performed, was distributed. Community Blood Centers of Florida, Inc.
Food Aunt Marie's Bakery Gourmet Cookie Dough, Chocolate Chunk, packaged in 3-lb. plastic tubs. Distributed by Racine Danish Kringles, Racine, WI. Lot 12005 Class II Foreign object in cookie dough RDK Corp
Biologics Cornea 1106057COS; 1101093CODG1; 1101093CODG2; 1101093COSG1; 1101093COSG2; 1103009COD; 1103009COSG1; 1103009COSG2; 1103042CODG1; 1103042CODG2; 1103042COS; 1104100COD; 1104100COS; 1105042COD; 1105042COSGW; 1105052COD; 1105052COS; 1106005COD; 1106005COS; 1106057COD; 1107047COD; 1107047COS; 1109010COD; 1109010COS; 1110020CODG1; 1110020CODG2; 1110020COSG1; 1110020COSG2; 1203082COD; 1203082COS; 1204060COD; 1204060COS; 1206025COD; 1206025COS; 1105073-COD; 05073COS Class III Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Food ***Fresh Point***Fresh Cuts***Service Salsa Mango***2 x 5lb Tray***Net Wt. 50 lb.*** Item # 302940 - Used by date 08/04 though 08/17 or Julian production date 215 through 230 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA. FreshPoint South Florida
Food ***Fresh Point***Fresh Cuts***Fruit Mango/Papaya Diced***2 x 5lb Tray***Net. Wt. 10 lb.*** Item # 300735 - Used by date 08/04 though 08/17 or Julian production date 215 through 230 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA. FreshPoint South Florida
Food ***Fresh Point***Fresh Cuts***Salsa Mango and Papaya*** 2 x 5lb Tray***Net Wt. 10 lb.*** Item # 302942- Used by date 08/04 though 08/17 or Julian production date 215 through 230 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA. FreshPoint South Florida
Food ***Fresh Point***Fresh Cuts***Retail Mango Sliced***6 X 8oz Cups Packages***Net Wt. 27 lb.*** Item # 301348 - Used by date 08/04 though 08/17 or Julian production date 215 through 230 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA. FreshPoint South Florida
Food Fresh Mango peeled and cut into cubes, slices, or halves labeled as listed: ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD Cubed 1/2***2 x 5lb Tray***Net Wt. 310 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango Peeled / Halved***2 X 2.5 lb Tray***Net Wt. 245 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Sliced***2 x 5lb Tray***Net Wt. 30 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Cubed 1***2 x 5lb Tray***Net Wt. 30 lb. Item # 380780, 300825, 300810, 300760 - Used by date 08/04 though 08/17 or Julian production date 215 through 230 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA. FreshPoint South Florida
Devices HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116. Class II Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. Terumo Cardiovascular Systems Corporation
Devices Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05. Class II Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. Terumo Cardiovascular Systems Corporation
Biologics Amniotic membrane 2012838004; 2012838005; 2012838006; 2012838007; 2012838008; 2012838009; 2012838010; 2012838011; 2012838012; 2012838013; 2012838014; 2012838015; 2012838016; 2012838017; 2012838018; 2012838019; 2012838020; 2012838021; Class II Amniotic membrane allografts, recovered from a donor whose preprocessing tissue culture indicated growth of Group D Enterococcus, were distributed. Surgical Biologics LLC
Food American Vines band Natural Vines Black Soft Licorice Twists; All Natural Ingredients, 8 oz (226g), No Preservatives, Product is processed and packaged by American Licorice Company, Union City, CA; Displays and Pallets info: ----6 ct. Case, Item: #8483, Case UPC: 00-41364 08483-8; ----12 ct. Case, Item: #8481, Case UPC: 100-41364 08481-4; ----36/8oz Combo Floor Display (Black Only), Item: #8484, Item UPC: 041364084817, Case UPC: 100-41364 08484-5; ----18/8oz Combo Wing Display (Black Only), Item: #8485, Item UPC: 041364084817, Case UPC: 100-41364 08485-2 Affected Date Codes: 01 04 13, 01 05 13, 01 26 13, 01 27 13, 03 02 13, 03 16 13, 04 07 13, 04 09 13, 04 19 13; Date Code is printed on white sticker located on back of package Class II Firm's internal sampling of the product found elevated levels of lead in the product. American Licorice Co
Food Salmon Wrap. Two wraps per package. Net Wt 8 oz Lot Expiration: 06/11/2012 through 11/15/2012 Class II Product manufactured using cooking spray which contains soy oil and soy was not declared on the label. Taco Loco Products Inc
Drugs Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9. Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15 Class III CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt. ITW Dymon
Food Ice Cream - label reads in part "*** Lovin' SCOOPFUL CHURNED LIGHT ICE CREAM *** SUPER DUPER PEANUT BUTTER CUP*** all codes Class I The firm received product from a raw material supplier which was recalled by Sunland, Inc. the raw material has the potential to be contaminated with Salmonella Super Store Industries
Devices Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. Lot 1108-01 Class II Some of the sterile packages had broken seals. Progressive Medical Inc
Devices Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening. Part number 390.007, Lot number 6800599 Class II The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. Synthes USA HQ, Inc.
Food Pierre Peanut Butter & Grape Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 71421921205, Lot Codes: 1080123, 1080589 & 2040471, Exp dates: 5/12/12, 5/18/12 & 1/21/13; Lot Codes: 1070182, 1070188, 107018A, 1070205, 1080079, 1080590, 1080631, 2020626 & 2030538 and Lot Codes: 1070232, 1080112, 1080120, 1080576, 1090133. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Strawberry Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 71421921212, Lot Code: 1080124, Exp date: 5/29/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Grape Jelly on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999110047, Lot Codes: 1070195, 1070209 & 1090328, Exp dates: 8/14/12, 9/2/12 & 9/7/12 and Lot Codes: 1070189, 1070197, 1070206, 1070471, 1070535, 1080080, 1080125, 1080314, 1080505, 1080865, 1090039, 1090086, 1090131, 1090289, 2020162, 2020638, 2030158, 2030335 & 2030839. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Jelly Squarewich, 2.70oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999210051, Lot Code: 2030322, Exp. date: 12/5/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food PB & J Jamz, 2.80oz., Distributed by: AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 605388670137, Lot Codes: 1070172, 1070178, 1070191, 1070192, 1070193, 1070207, 1070208, 1070507, 1070630, 1080001, 1080150, 1080322, 1080728, 1080834, 1080835, 1090001, 1090127, 2020624, 2030324, 2030339, 2040147, 2040214 & 2040604, Exp. dates: 4/12/12, 4/14/12, 4/24/12, 5/2/12, 5/3/12, 5/23/12, 5/22/12, 4/13/12, 4/28/12, 4/27/12, 5/28/12, 5/21/12, 5/24/12, 5/21/12, 6/4/12, 5/25/12, 5/29/12, 1/19/13, 12/5/12,  ...
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Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Jamwich Crustless Peanut Butter & Jelly Sandwich, 2.8oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999112805, Lot Code: 2030545, Exp. date: 1/7/13. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Strawberry Jelly on White, 8/12PK, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999213687, Lot Code: 1080122, Exp. date: 5/2/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Market Day, Peanut Butter & Jelly Grahamwich, 12/2.20oz., Manufactured for: Market Day, Inc., Itasca, IL 60143. UPC Code: 75999213748, Lot Codes: 1080571, 1080667, 1080825 & 2030374, Exp. dates: 5/14/12, 5/28/12, 6/5/12 & 12/31/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre On The Go PB Jamwich Honey, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999213393, Lot Codes: 1070174, 1070214, 1070241, 1070610, 1070658 & 1080292, Exp. dates: 4/16/12, 5/15/12, 4/18/12, 4/17/12, 4/19/12 & 5/1/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre On The Go PB Jamwich Grape, 2.00oz, Pierre On The Go PB Jamwich Grape, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 759992133946, Lot Codes: 1070533, 1070534, 1080053, 1080054, 1080646 & 1080855, Exp. dates: 4/22/12, 4/23/12, 5/1/12, 4/30/12, 5/17/12 & 5/21/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food PB & Grape Jamwich, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999613968, Lot Codes: 1070180, 1070181, 1070316, 1070466, 1070467, 1070468, 1070469, 1070547, 1080048, 1080305, 1080570, 1090087, 2020071 & 2020629, Exp. dates: 4/27/12, 4/26/12, 4/13/12, 5/7/12, 5/8/12, 5/20/12, 5/19/12, 4/15/12, 4/28/12, 5/28/12, 5/27/12, 6/5/12, 12/4/12 & 1/7/13. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food PB & Grape Jelly on Whole Grain Graham Wafers, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999200595, Lot Code: 2050305, Exp. date: 2/12/13 and Lot Codes: 1080651, 1080813, 1090278 & 2020608. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter Cup, 1.11oz., AdvancePierre, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 462476. Lot Codes: 1080118, 1080295, 1090009, 2020043, 2020645, 2030820 & 2030822. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Grape Jelly Cups., 1.50oz. and 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. Lot Code: 1070233 (1.50oz) and Lot Codes: 1070485, 2020046, 2030542, 2030818 & 2030819 (2.80oz). Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Straw Jam on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. Lot Codes: 1080731, 1090099 & 1090132. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Peanut Butter & Jelly on Graham Wafers, 2.20oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. Lot Codes: 1070218-1070220, 1070748, 1070753, 1070756, 1070799, 1070829, 1080129, 1080130, 1080132-1080135, 1080293, 1080466, 1080572, 1080573, 1080575, 1080734, 1080814-1080816, 1080905, 1080906, 1090057, 1090139, 1090222, 1090280, 1090391, 1090612, 2020057, 2020058, 2020612, 2020613, 2020615-2020618, 2030544, 2030860, 2040181, 2040183-2040186 & 2050260. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter & Straw. Jam on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. Lot Codes: 107017A, 1070465 & 1080437. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre Peanut Butter Jamwich & Banana on Whole Grain Bread, 2.80oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. Lot Code: 1070194. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Pierre On The Go Peanut Butter + Strawberry Jam, Jamwich, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. UPC Code: 75999213392, Lot Codes: 1070175, 1070186, 1070200, 1070659 & 1080671, Exp. dates: 4/21/12, 4/29/12, 5/16/12, 4/20/12 & 5/17/12. Class I Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella. Advance Pierre N
Food Organic Toffee Peanuts;Bulk packaging - 20 pound cases; Ingredients: Organic Peanuts, Organic Sugar, Salt. Item No, 600-72445 Lot No: 100401, 100402, 100514, 100624, 100907, 100908, 101112, 101115, 110413, 110614, 110718. Class I Sconza Candy Company is recalling organic toffee peanuts that were manufactured with peanuts from Sunland which are under recall because of the possibility of Salmonella contamination. Sconza Candy Company, Inc.
Devices ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Catalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE,  ...
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Class II Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the control board. Zimmer, Inc.
Food Whole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222 Sell by dates: 10/8/2012 and 10/10/2012 Class II Label fails to declare tree nuts (almond and cashews) in the "Contains:" allergen statement. Whole Foods Market Group Inc.
Biologics Cornea 110227100, 110227200 Class II Human Corneas, recovered from a donor who had not been properly evaluated, were distributed. Oklahoma Lions Eye Bank
Food Iskream brand Peanut Butter and Jelly No Sugar Added, reduced fat, packaged in Pint (retail) an 2.5 gallon bulk cartons All lot codes Class I Ice Cream manufactured with Sunland recalled peanut butter has the potential to be contaminated with salmonella Bucks Ice Cream
Food Kentucky Rose, blue cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap Kentucky Rose, blue cheese Lot #120531 Class I Due to possible Listeria monocytogenes contamination Kennys Farmhouse Cheese
Food Kentucky Blue, bleu cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap Lot 120531 Lot 120612 Class I Due to possible Listeria monocytogenes contamination Kennys Farmhouse Cheese
Food Awe Brie Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap Lot 120716 Lot 120629 Lot 120614 Class I Due to possible Listeria monocytogenes contamination Kennys Farmhouse Cheese
Food Tomme de Nena Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap Lot 120716 Lot 120614 Class I Due to possible Listeria monocytogenes contamination Kennys Farmhouse Cheese
Food Albertsons Peanut Butter Cup Ice Cream, 1.5 QTS (1.42 L)(vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls) UPC 41163 45891, any Best By or EXP dates ranging from 4/06/2011 to 9/25/2013, Plant Code 49-11 or 06-20. Class I Product was manufactured using an ingredient that was recalled due to Salmonella contamination. Dean Foods Company
Food Albertsons Peanut Butter Chocoate Ice Cream, 1.5 QTS (1.42 L), (chocolate ice cream with a peanut butter swirl) UPC 41163 45903, any Best By or EXP dates ranging from 3/26/2011 to 8/03/2013, Plant Code 49-11 or 06-20. Class I Product was manufactured using an ingredient that was recalled due to Salmonella contamination. Dean Foods Company
Food Western Family "Creamery Select" Premium Ice Cream Peanut Butter Cup, 1.5 QTS (1.42 L), (vanilla ice cream with peanut butter cup pieces, fudge swirl, and peanut butter ribbon) UPC 15400 21432, any Best By dates ranging from 9/09/2011 to 10/03/2013, Plant Code 49-11. Class I Product was manufactured using an ingredient that was recalled due to Salmonella contamination. Dean Foods Company
Food Prime Time brand Buckeye Bites Ice Cream in a paper carton 48 oz containers and 3 gallon tubs Lot codes between Feb 11 2012 and Mar 14 2013 Class I Product was manufactured using an ingredient that was recalled due to Salmonella contamination. Toft Dairy Inc
Food Frozen Publix Brand Premium Tempura Shrimp, 11 oz box packed 10 boxes per case. Production Codes: 668/30WI, 668/01DI, 668/03DI, 668/04DI, 668/06DI, 668/08DI, 668/10DI, 668/11DI, 668/13DI, 668/15DI, 668/18DI, 668/20DI Class I On 10/16/2012, Publix Super Markets, Inc. recalled their Publix Premium Tempura Shrimp because it was discovered that a dipping sauce packet was included in the box with the shrimp. The sauce contains undeclared soy. Publix Corporate Office
Food Mazzio's Marinara Sauce, 6.65-lb pouch, 6 pouches per case Pouches are packed in cardboard box for shipment Lot Numbers: 101141 101195 101253 101304 Class II The ingredient statement does not declare milk as the source of the butter on the label. Paradise Tomato Kitchens Inc
Drugs All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II GMP Deviations New England Compounding Center
Devices ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer. Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. Class III This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay. Horiba Instruments, Inc dba Horiba Medical
Food Peanut Butter Pave, UPC code 693868102117 & 69386905312, in the following sizes: 1) 5 Piece Peanut Butter Pave, 63 Grams per pack, 12 Packs per case. 2) 2 Piece Peanut Butter Pave, 26 Grams per pack, 10 Packs per case. 3) Bulk Peanut Butter Pave, 415 Grams per pack. Lot #'s 12031, 12046, 12159, 12201 Class I The product has the potential to be contaminated with Salmonella. B.T. McElrath Chocolatier, Inc
Drugs All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com All lot codes within expiry Class II Lack of assurance of sterility Ameridose LLC
Drugs All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com All lot codes within expiry Class II GMP deficiencies Ameridose LLC
Devices TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01 Class II Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in the patient. Trivascular, Inc
Biologics Product Name: LABType® HD Class II DRB1 Typing Test Product Number: RSSOH2B1/RSSOH2B1X Lot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21 Lot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21 Class II HLA typing assay, associated with incorrect typing results, was distributed. One Lambda Inc
Devices Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination. Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635. Class II Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale. Gulf South Medical Supply Inc
Biologics Multispot HIV-1/HIV-2 Rapid Test has a catalog # 25228. Expiration date:April 23, 2013 Class III Bio-Rad Multispot HIV-1/HIV-2 Rapid Test, with reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membrances when using some vials of Conjugate, were distributed. Bio-Rad Laboratories
Drugs Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 Lot # A00984 Exp. 01/14 Class III Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." Stat Rx USA
Devices EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications. INFKIT2 with serial numbers: 506249031, 506264096, 506272024, 506335006, 506335145, 506336089, 506336096, 506362083, 506362086, 507018037, 507018060, 507067220, 507085140, 507087018, 507087140, 507095089, 507095171, 507121102, 507122050, 507122066, 507123149, 507123163, 507144016, 507144057, 507144215, 507144220, 507144221, 507144226, 507151002, 507155019, 507155021, 507155094, 507155127, 507155156, 507155159, 507156065, 507157048, 507157124, 507164009, 507173005, 507173019, 507173063, 507179123, 507180064, 507186018, 507186098,  ...
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Class II MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely. MOOG Medical Devices Group
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