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U.S. Department of Health and Human Services

Enforcement Report - Week of January 13, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations. Model Number: PPC484, Lot Numbers: 970773, 977566, 987984, 1003033, 1038519, 1038520, 1045556, 1046268, 1054540, 1059416, 1059512, 1065495, 1065497, 1071762, 1071763, 1073161, 1073163, 1108328, 1128077, 1139601, 1141281, 1141282, 1150838, 1153463, 1165800, 1167709, 1171489, 1172858, 1173629, 1179005, 1183068, 1184510. Model Number: PPC485, Lot Numbers: 1071764, 1071765, 1118826, 1143159, 1171487, 1178795, 1179690. Model Number  ...
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Class II Inadequate biocompatibility. Biomet 3i, LLC
Devices BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations. Model Number: PAK4140, Lot Numbers: 977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 1010960, 1014334, 1015290, 1040122, 1040123, 1041414, 1045559, 1051854, 1052717, 1057786, 1062286, 1062287, 1062316, 1062317, 1065506, 1069146, 1069147, 1069996, 1075432, 1077541, 1077695, 1079484, 1087552, 1092512, 1095127, 1101673, 1108857, 1116020, 1124781, 1126602, 1133466, 1138040, 1142164, 1142165, 1142166,1142167, 1146388, 1146389,  ...
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Class II Inadequate biocompatibility testing. Biomet 3i, LLC
Devices BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations. Model Number: PIC484, Lot Numbers: 942680, 950198, 950706, 957203, 963249, 973436, 977567, 993384, 1004520, 1015298, 1024240, 1034518, 1048991, 1057119, 1095480, 1105770, 1131300, 1133485, 1158650, 1165796, 1169295, 1172741, 1175519, 1178568, 1181589, 1184490; Model Number: PIC484H,  ...
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Class II Inadequate biocompatibility. Biomet 3i, LLC
Devices BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations. Model Number: PRK484, Lot Numbers: 929282 , 948311, 949496, 949497, 949668, 950083, 952452, 954303, 957220, 957368, 960733, 963052, 963054, 971802, 975153, 977973, 979767, 984897, 987880, 989210, 992599, 996689, 1001596, 1004143, 1008573, 1012089, 1013629, 1015576, 1023526, 1030628, 1033053, 1036120, 1041405,1044169,1046263, 1055914, 1055916, 1062672,1062819,1063241, 1064625,1065949, 1069639, 1071532, 1073172, 1075436, 1079918, 1083264, 1086406,  ...
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Class II Inadequate biocompatibility. Biomet 3i, LLC
Food David Trail Mix Sweet & Salty individual plastic bags net wt. 5 oz. (142 g) UPC 00 26200 23885 2 shipped in the following configurations: 1) cases of eight (8) with UPC 20-0-26200-23885-6; 2) 36-count multi-pack shipper case UPC 00-0-26200-23890-6 which contains 16 individual 5.25 oz. bags of Classic flavor and 20 individual 5 oz. bags Sweet & Salty flavor UPC 00 26200 23885 2; and 3) 24-count snack rack case UPC 27000-82339 store display which contains individual 5 oz. bags Sweet & Salty flavor UPC 00 26200 23885 2. All lots distributed since 11/14/2012. Class I Product contains undeclared milk. ConAgra Foods Inc
Food Skinny Latina Million Dollar Marinade, 12 oz, shelf stable, dry storage. UPC #8-55329-00400-6; Lots 12/02/15A, 12/02/15B, 10/21/15A, 10/21/15B, 10/22/15A, 10/22/15B, 10/23/15A, 10/23/15B, 10/24/15A, 10/24/15B, 10/28/15A, 10/28/15B, 10/27/15A, 10/27/15B, 10/29/15A, 10/29/15B Class I Undeclared soy Skinny Latina LLC
Devices Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071 Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086 Lot Numbers: 215166002, 215194002, 215222002, 215271002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic Lot Numbers: 405131002, 405173002, 405187002, 405208002, 405229002 405278002, 405292002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079 Lot Numbers: 515146002, 515201002, 515285002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068 Lot Numbers: 245138002, 245152002, 245215002, 245262002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus® CS analyzer Catalog Number: CCCRP SMN:10445066 Lot Number: 425229002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060 Lot Numbers: 445146002, 445201002, 445243002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067 Lot Numbers: 625229002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061 Lot Numbers: 625229002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic Lot Numbers: 815131002, 815222002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Devices Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070 Lot Numbers: 845173002 Class II Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Siemens Healthcare Diagnostics Inc
Drugs EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482. Lot # U150511; Exp. 05/18 Class III Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it PQ Corporation
Devices Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less. HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001. Class II Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit. Maquet Cardiovascular Us Sales, Llc
Food Casey's Bakery, 8X8 Snickers cake, www.caseysbakery.com, Sioux Center, IA All date codes earlier than 696 Class I Product contains undeclared peanuts Casey's Bakery, Inc
Food Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case UPC # 720379585044 Class II Made in Nature is recalling Made In Nature Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips due to undeclared soy allergen from Tamari. Made In Nature, LLC
Food Pacific Superfoods Snack Lava Rock Sriracha Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case UPC # 850747004102 Class II Made in Nature is recalling Made In Nature Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips due to undeclared soy allergen from Tamari. Made In Nature, LLC
Devices NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¼ inch. Item code FS+173230BC. Model No.: FS+173230BC, Lot #14A22 and Lot #14A26. Class III Device has the potential to have torn wings. Nipro Medical Corporation
Devices CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters. Serial numbers: 003040i-2014-161-014-GG-0000, 003040i-2015-101-003-GG-0000, 003040i-2014-161-001-GG-0000, 003040i-2014-161-002-GG-0000, 003040i-2014-161-003-GG-0000, 003040i-2014-161-004-GG-0000, 003040i-2014-161-005-GG-0000, 003040i-2014-161-006-GG-0000, 003040i-2014-161-007-GG-0000, 003040i-2014-161-008-GG-0000, 003040i-2014-161-009-GG-0000, 003040i-2014-161-010-GG-0000, 003040i-2014-161-011-GG-0000, 003040i-2014-161-012-GG-0000, 003040i-2014-161-013-GG-0000, 003040i-2014-161-015-GG-0000, 003040i-2014-161-016-GG-0000, 003040i-2014-161-017-GG-0000, 003040i-2014-161-018-GG-0000, 003040i-2014-161-019-GG-0000, 003040i-2014-161-020-GG-0000, 003040i-2014-161-021-GG-0000, 003040i-2014-161-022-GG-0000, 003040i-2014-161-023-GG-0000, 003040i-2014-161-024-GG-0000, 003040i-2014-161-025-GG-0000, 003040i-2015-101-001-GG-0000, and 003040i-2015-101-002-GG-0000 Class II Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure). Partners In Medicine Llc
Devices The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock. Item Number G03974 Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U Class I Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient. Stryker Sustainability Solutions
Devices BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR HEAD 42 MM -4 (SHORT) 74121346, MODULAR HEAD 46 MM -4 (SHORT) 74121350, MODULAR HEAD 50 MM -4 (SHORT) 74121354, MODULAR HEAD 54 MM -4 (SHORT) 74121358, MODULAR HEAD 58 MM -4 (SHORT) 74121438, MODULAR HEAD 38 MM +0 (MED) 74121442, MODULAR HEAD 42 MM +0 (MED) 74121446, MODULAR HEAD 46 MM +0 (MED) 74121450, MODULAR HEAD 50 MM +0 (MED) 74121454, MODULAR HEAD 54 MM +0 (MED) 74121458, MODULAR HEAD 58 MM +0 (MED) 74121538, MODULAR HEAD 38 MM +4 (LONG) 74121542, MODULAR HEAD 42 MM +4 (LONG) 74121546, MODULAR HEAD 46 MM +4 (LONG) 74121550, MODULAR HEAD 50 MM +4 (LONG) 74121554, MODULAR HEAD 54 MM +4 (LONG) 74121558, MODULAR HEAD 58 MM +4 (LONG) All codes Class II The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use. Smith & Nephew, Inc.
Devices Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November  ...
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Class II Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Corflex
Devices Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer . Model 8104, Lots: 18279548, 18279734, 18324877, 18329863, 18330946, 18348755, 18351569, 18353214, 18426640, 18461104, 18461521. Model 8105, Lots: 18281110, 18315176, 18322343, 18323156, 18323651, 18324468, 18327210, 18327359, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459,  ...
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Class II Potential for separation of the proximal handle from the shaft. Boston Scientific Corporation
Devices NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis. lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701) Class II A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. Zimmer Manufacturing B.V.
Devices Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Software Version: SW VD-10E Class II Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged. Siemens Medical Solutions USA, Inc
Devices ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture. Class II There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters. KCI USA, INC.
Devices Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062 Class II During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Devices SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures. Part number: 352.135; Lot number: F-17180 Class II The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm. Synthes (USA) Products LLC
Devices 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton) Class II Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe. 3M Company - Health Care Business
Devices Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device. Lot Numbers: GR323998, GR325035, GR326082, and GR327965 Class II Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Baxter Healthcare Corp.
Devices Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. . Lot Numbers: GR324012, GR325322, GR326769, and GF328518 Class II Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Baxter Healthcare Corp.
Devices Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container. Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534 Class II Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Baxter Healthcare Corp.
Devices Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously. Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557. Class II Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently complained of the system freezing and it could only be restarted if the user re-applied power. Vidco, Inc.
Drugs 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China Lot# F11641, Exp 9/17/2016 Class III Subpotent Drug Freedom Pharmaceuticals Inc
Food BAKERY FRESH GOODNESS Chocolate Brownie NET WT 16 OZ (1 LB) 453 g CONTAINS: MILK, EGGS, WHEAT, SOY. MAY CONTAIN: ALMONDS, PECANS, WALNUTS, CASHEWS, COCONUT. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 09172 7 Lot 15307 Sel By 02 Aug 2016 Class I The firm was notified by a consumer of undeclared walnuts in the product. The Kroger Co
Devices InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion. lot#s BC2GN and BC4L7 Class II Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed. Ultradent Products, Inc.
Drugs Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP - GenAR, Active Pharmaceutical Ingredient, 100 LB Drum. Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034 Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17. Class III Failed Impurities/Degradation Specifications: Out of specifications results for impurities. Avantor Performance Materials Inc
Devices AMSCO® Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications. Serial #'s: 0428014026 - 0432115014 Class II The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature. Steris Corporation
Food Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 UPC 884678102323 Class II This recall has been initiated because the laboratory analysis indicates that the product contains FD & C Red #3, and Yellow #5 which are not declared on the ingredient statement on the product label. Nicomex Inc.
Food Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code - 698768102120 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb Holiday Gathering COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4034 UPC Code - 698768034346 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb Fairytale Princess COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4031 UPC Code - 698768034315 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb Monster Bash COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4032 UPC Code - 698768034322 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb Birthday Celebration COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4033 UPC Code - 698768034339 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb HELLO KITTY COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4035 UPC Code - 698768034353 Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2lb DSC Custom Decorated Sugar Cookies Item # 101-2207 thru 101- 2355 UPC Code - None Dates codes: 10/9/15 11/23/15 (Julian Dates - 15282 - 15327) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Food Crazy about Cookies 2.7lb WALNUT CHUNKY CHOCOLATE CHIP Pre-Portioned cookie dough Item # 25-2008 UPC Code - 698768102168 11/24/15 (Julian Date 15328) Class I Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg. Pine Valley Foods Inc
Devices Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE® III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. TC003 (US Only) TC013 (US Only) TC033 (OUS Only) TC043 (OUS Only). Code, Batch: TC04320, GMMG07; TC00320, GMMG08; TC00320, GMMG09; TC00320, GMMG10; TC04320, GMMG11;  ...
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Class II Stability data does not substantiate the labeled two-year shelf life of affected product. Ethicon, Inc.
Devices MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada Lots 114842, 116433 & 118251 Class II The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. Benlan, Inc.
Devices Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant. Batch # 15GM07831 Class II One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation. Smith & Nephew, Inc.
Devices Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Versions 3.3 and higher Class II When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume. Elekta, Inc.
Devices Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) System Serial numbers: USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; USN15L0863; USN15L0864; USN15L0865; USN15L0866; USN15L0867; USN15L0917; USN15L0918; USN15L0988; USO15L0563; USO15L0564; USO15L0565; USO15L0566; USO15L1087; and USO15L1088. Class II Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies. Philips Ultrasound, Inc.
Drugs Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04. Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16. Class II cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. PD-Rx Pharmaceuticals, Inc.
Drugs Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07. Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73,  ...
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Class II cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. PD-Rx Pharmaceuticals, Inc.
Devices Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb. All serviced between 27 April 2015 and 17 November 2015 Class II Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair. Otto Bock Healthcare GmbH
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