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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells. 5318209 Class II Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed. Florida Blood Services, Inc.
Biologics Cryoprecipitated AHF 084FT06904, 084FT06961, 084FT07108, 084FT07114, 084FT07188, 021LC88992, 084FT07115, 084FT07117, 084FT07155, 084FT07157, 084FT06946, 084FT07211, 021LK33581, 021LC88495, 084FT07300, 084FT07101, 084Q 49296, 084FT07112, 084K 90768, 084K 91006, 084Q 49188, 021LC89396, 021LG50163, 021LH48240,021KS63809, 021KS63820, 021LJ44014, 021LJ44023, 021LK33463, 021LK33471, 084K 91594, 021KS63816, 084FT07855, 084FT07858, 084FT07860, 084FT07895, 084FT02469, 084K 91668, 084FT07872, 084Q 50129, 084W 89449, Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. American National Red Cross (The)
Biologics Source Plasma 368059868 Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 368066965 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 368092877 Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 368095570 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 4270133819; 4270132571; 4270131033; 4270129823; 4270128160; 4270127401; 4270126368 Class II Blood products, collected from a donor whose annual physical examination was inadequately documented, were distributed. Csl Plasma Inc
Biologics Source Plasma 368078740, 368078739, 368078741, 368078742, 368078743, 368078744, 368078745, 368078746, 368078747, 368078749, 368078750, 368078751 Class III Source Plasma, which reached unacceptable temperatures during storage and was not relabeled as Source Plasma, Salvaged, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 368096614 Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Source Plasma 4270183014, 4270181851, 4270180003, 4270174788, 4270173161, 4270171887, 4270165471, 4270162492, 4270161125, 4270160357, 4270159126, 4270157892, 4270157329, 4270155736, 4270155211, 4270153782, 4270153425, 4270152091, 4270151567, 4270150167, 4270148507, 4270147032, 4270146491, 4270145367, 4270144221, 4270143653, 4270141052, 4270139728, 4270139214, 4270138216, 4270137713, 4270136676, 4270136156, 4270134929, 4270134542, 4270131147, 4270129852 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Csl Plasma Inc
Biologics Source Plasma 366027304, 366026831, 366025874, 366025391, 366024924, 366024530, 366024101, 366023644, 366023243, 366022718, 366022200, 366021598, 366021268, 366020655, 366020302, 366019234, 366018953, 366018335, 366017996, 366017369, 366017045, 366015267, 366014368, 366014020, 366013394, 366013081, 366010974, 366010638, 366009925, 366009630, 366005720, 366005669, Class II Blood products, collected from a donor with a history of incarceration, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 368113477, 368113196, 368112733, 368112468, 368111928, 368111524, 368110980, 368110672, 368110337, 368109593, 368109176, 368108774, 368108556, 368105673, 368105400, 368105048, 368104748, 368104352, 368104082, 368103299, 368102857, 368102609, 368102190, 368101662, 368101408, 368100001, 368099530, 368099017, 368098657, 368097870, 368097647, 368097193, 368096831, 368095975, 368095635, 368095159, 368095028, 368094533, 368094268, 368093898, 368093518, 368093303, 368092635, 368092317, 368091546, 368091172, 368090881, 368089542, 368089273, 368087926,  ...
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Class III Blood products, collected from a donor who was deferred for a history of Hepatitis A, were distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Red Blood Cells Leukocytes Reduced W045008125859; W045008120117; W045008117463; W045008111946; W045008110989; W045008125925; W045008108260; W045008120091; W045008108305; W045008125939; W045008120163; W045008117428; W045008111068; W045008105566; W045008125812; W045008120184; W045008115702; W045008120115; W045008129826; W045008125919; W045008125203; W045008115685; W045008119980; W045008913232; W045008129832; W045008125399; W045008108310; W045008125660; W045008125922; W045008119876; W045008115637; W045008108306; W045008108304; W045008108294; W045008097193; W045008125923; W045008119838; W045008117459; W045008111075; W045008108333; W045008108327; W045008108321; W045008115778; W045008110803; W045008108721; W045008125941; W045008125678; W045008120106; W045008120097;W045008125943; W045008125813; W045008120092; W045008119995;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center Of Gtr KC
Biologics Plasma Frozen Within 24 Hours After Phlebotomy (FP24) W045008120117; W045008117439; W045008117425; W045008119923; W045008119929; W045008111075; W045008120118; W045008117428; W045008913211; W045008115790; W045008111068; W045008110803; W045008095756; W045008111946; W045008108338; W045008108721; W045008119951; W045008119995; W045008119926; W045008108796; W045008120116; W045008129855; W045008129852; W045008120025; W045008119991; W045008119893; W045008117463; W045008115778; W045008115702; W045008115633; W045008111976 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 30GV71292, 30GV71597, 30GX30904, 30GX32297, 30FN31824, 30FN31831, 30FN32575, 30FN34189, 30GT60367, 30GT60470, 30GT60478, 30GT60484, 30GV69491, 30GV69638, 30GX32685, 30GX32718, 30GX32738, 30GX32923, 30GX32957, 30GY87076, 30GY87106 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 30GV71814, 30FN33298, 30FW61951, 30FW62308, 30GZ19273 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 30LM02557 (Parts 1 and 2) Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 0090991017, 0090990692, 0090990207, 0090989917, 0090989427, 0090989110, 0090988619, 0090986626, 0090986135, 0090985782, 0090984487, 0090983458, 0090982937, 0090982638, 0090982076, 0090981765, 0090981181 Class II Blood products, collected from a donor who did not have a physical examination, were distributed. Biotest Pharmaceuticals Corporation
Biologics Source Plasma 5250051627, 5250051321, 5250050643, 5250050422, 5250049708, 5250049571, 5250048584, 5250047966, 5250047708, 5250046985, 5250046641, 5250046068, 5250045742, 5250045161, 5250044825, 5250044144, 5250043890, 5250042937, 5250041894, 5250041609, 5250040334, 5250040089, 5250038529 Class III Source Plasma, collected from donors who did not have a complete medical history interview, was distributed. Octapharma Plasma, Inc.
Devices CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046, 1047,1049-1053,1059,1063,1066-1071,1075,1096,1097,1101-1105, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063,  ...
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Class II Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. Terumo Cardiovascular Systems Corporation
Devices CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 1310, 1311, 1316-1320, 1322-1331,1335-1339,1345-1349,1359, 1378,1384-1388, 1394-1398,1409-1413,1419,1434-1438,1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493,1495-1503,1505-1520,1528,1531-1553, 1555-1558,1567-1596,1607-1616,1632-1636,1647-1656,1667-1671,1677-1681,1687-1696, 1702-1711,1717-1721,1728-1732,1738-1753, 1759-1775,1777-1786,1790-1794,1796-1804,1810-1814,1820-1829,1831-1843,1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915,1921-1925,1931-1935,1941-1950,1975,1986-2015, 2017-2022, 2024-2028, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118- 2122,  ...
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Class II Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. Terumo Cardiovascular Systems Corporation
Devices CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579. Class II Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. Terumo Cardiovascular Systems Corporation
Devices CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349. Class II Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. Terumo Cardiovascular Systems Corporation
Devices CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog number: 500V* and serial numbers: 1564-1566 Class II Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. Terumo Cardiovascular Systems Corporation
Devices Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. All serial numbers manufactured Class II St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. St. Jude Medical
Devices Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. All serial numbers manufactured Class II St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. St. Jude Medical
Food Item # H996189 Mango Diced 1/2" 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0908 and 0913 located on top film of tray and also on the outer box. Class I The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella. MR Cuts, L.p.
Food Item # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0909 and 0908 located on top film of the tray and also on the outer box. Class I The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella. MR Cuts, L.p.
Food Item # 2999 Mango Chunks 2/5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico All mango products manufactured from mangos sourced by Agricola Daniella. Lot Number 0913 located on top film of the tray and also on the outer box. Class I The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella. MR Cuts, L.p.
Drugs Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14 Class I Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. Apotex Corp.
Biologics Red Blood Cells Leukocytes Reduced W121013003828; Class II Blood product, with an unacceptable low volume which was not labeled as a low volume unit, was distributed. Marquette General Hospital, Inc, UP Reg Bl Ctr Marquette
Biologics Source Plasma 42203722165; Class II Blood product, tested for viral markers using a sample that was diluted with saline, was distributed. CSL Plasma, Inc.
Biologics Blood and Blood Products for Reprocessing W115911282177; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115911282177; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 7188318; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 7188318; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Fresh Frozen Plasma W140912138630; 2488230; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Red Blood Cells Leukocytes Reduced W140912138630; 2488230; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Platelets 2488230; Class III Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced W117010183953S, W1170081297363, W117008114557A Class III Blood products, which did not meet the minimum requirement for Red Blood Cell recovery, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W0410130318458 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Systems Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W117013227836E (2 units) Class II Blood products, for which the quality control testing was not performed, were distributed. Blood Centers of the Pacific - Irwin Center
Devices KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients. Lot Number: 002876-007R Class II One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. SpineFrontier, Inc.
Biologics Red Blood Cells W036810221666; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036810221666; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Plasma Frozen within 24 hours (FP24) 084FH15109; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American National Red Cross (The)
Biologics Source Plasma 3790257469; 3790257180; 3790256644; 3790256260; 3790255828; 3790255494; 3790255100; 3790254863; 3790254530; 3790254270; 3790253472; 3790252922; 3790252673; 3790251933; 3790251841; 3790251087; 3790250939; 3790250281; 3790250177; 3790249386; 3790249125; 3790248527; 3790248244; 3790247722; 3790247421; 3790246602; 37902246113; 3790245714; 3790245113; 3790244885; 3790244154; 3790244048; 3790243116; 3790242788; 3790242245; 3790241926; 3790241428; 3790241095; 3790240608; 3790240359; 3790239984; 3790239546; 3790239042; 3790238716; 3790238168; 3790237858; 3790237272; 3790236967; 3790236464; 3790236130;  ...
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Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Talecris Plasma Resources Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W051513048004; Class II Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed. Memorial Blood Centers
Biologics Red Blood Cells (Apheresis) W084713000100; W084713000100; Class II Blood products, which did not undergo the required quality control testing, were distributed. Central Blood Bank
Biologics Red Blood Cells (Apheresis) W085912007051; W086112001014; Class II Blood products, quarantined pending discard, were distributed Central Blood Bank
Devices Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems. 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches) Class II Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of United States origin, water, and/or cell growth promoting additives. Paa Laboratories Inc
Biologics Blood and Blood Products for Reprocessing W036812339618; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 001KM82603 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American National Red Cross (the)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037712052449; W037712052449; Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Platelets Pheresis Leukocytes Reduced W1151130719671; W1151130719671; W1151130719671; Class II Blood products, with platelet counts below the specified minimum requirement, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Blood and Blood Products for Reprocessing W037912159715; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W091013118069; W091013118069; W091013118069; Class II Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed. Oklahoma Blood Institute - Sylvan N Goldman Center
Devices B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers. All lot numbers Class II Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ß-CrossLaps (ß-CL) assay package insert version 5, could not be reproduced. The ß-CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosis in the short term. To date, no customer complaints have been reported. Roche Diagnostics Operations, Inc.
Devices Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures. The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054  ...
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Class II A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min. Leibel-Flarsheim Company LLC
Devices ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335. Class II Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010. Baxa Corporation
Biologics Vascular Graft 9863824; 9863853; 9863911 Class III Vascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Cardiac Tissue, Non-valved 9985176; 9985185 Class III Cardiac grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Vascular Graft 9962023 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Cardiac Tissue, Non-valved 9962099 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Heart Valve 9962113 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Vascular Graft 9832390; 9832483; 9840388 Class III Vascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Heart Valve 9860382 Class III Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Vascular Graft 9860472 Class III Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Cardiac Tissue, Non-valved 9860511 Class III Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. CryoLife, Inc.
Biologics Vascular Graft 10022449; 10022514; 10022551 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Heart Valve 10022483 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Cardiac Tissue, Non-valved 10022525 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Vascular Graft 9984625; 9984638 Class III Human vascular allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Heart Valve 9951484; 9951491 Class III Heart Valves, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Biologics Cardiac Tissue, Non-valved 9799209; 9856929 Class III Cardiac tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. CryoLife, Inc.
Devices Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. Lot/batch Number: CM040212; Exp. Date: April 2014 Class II Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label. Boston Scientific Corporation
Veterinary Pet Shoppe Chicken Jerky premium chicken dog treats, packaged in 20 ounce bags and 3.5 ounce bags. Distributed by Walgreen Co. Deerfield , IL Product Code: 7NPS420672 (3.5 ounce) and 7NPS420673 (20 ounce) Made in China Lot Number/Best By Date: Y101E28B12884 , 3.5 oz (Best By: 06/26/2014) Y101I16B15284 , 20 oz (Best By: 10/03/2014) Y101H29B15029 , 20 oz (Best By: 09/19/2014) Y101H16B12775, 20 oz. (Best By: 08/29/2014) Class II Pet treats contain trace amount of antibiotics RI Textile Company
Devices Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation. Model # 445226-0000-000 Class II Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate. Zeiss, Carl Inc
Devices Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current. Class II As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery. Integra LifeSciences Corporation
Devices MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine. All serial numbers Class I Miscalibrated Fill Level Sensor may affect dosing level Codman & Shurtleff, Inc.
Devices MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine. All serial numbers Class I Miscalibrated Fill Level Sensor may affect dosing level Codman & Shurtleff, Inc.
Food KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886. Batch: 13064 Class III Kenton's Cheese Co. is recalling Bianco A Soft Brie-Style Cheese due to E.coli contamination. Consumers who have purchased Bianco-Brie from Kenton's Cheese Co. between May 9, 2013 and May 19, 2013 listed with Batch number 13064, are urged to return the product to Kenton's Cheese Co. 5939 Burr Road Trumansburg, NY 14886. Questions may be directed to Kenton Burr (607) 592-0746 or via e-mail kenton@kentonscheeseco.com. A full refund will be provided by Kenton's Cheese Co. Kenton Burr
Devices Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices. Serial Number 0214200753 Class II The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance. Stryker Instruments Div. of Stryker Corporation
Devices CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices. Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593 Class II The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance. Stryker Instruments Div. of Stryker Corporation
Devices RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM). 0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193 Class II The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance. Stryker Instruments Div. of Stryker Corporation
Food PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801. Lot codes: C1306 through F1306 Class I Potential Salmonella contamination. Nassau Candy
Devices Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field. Models S099 and S099B Class II Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand. Edwards Lifesciences, LLC
Devices 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions. Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451. Class II Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected. Karl Storz Endoscopy America Inc
Drugs Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 Lot: LF01213A, Exp. 02/14 Class II Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. Sandoz Incorporated
Drugs Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. Lot #: 6003648, Exp. 6/2013 Class II Subpotent Drug; 15-month stability test station Fresenius Kabi USA, LLC
Drugs Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14 Class III Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050. Teva Pharmaceuticals USA, Inc.
Food RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap. The affected product includes finished product lot number 0943, which was made using supplier lot number PRO-1349. Class I Windy Acres Candy and Nut recalled the affected product because they were informed by the supplier, Lipari Foods, that the sunflower seeds were potentially contaminated with Listeria monocytogenes. Windy Acres Candy & Nut, Outlet Inc.
Devices nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis. Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220  ...
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Class II STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. Staar Surgical Co.
Devices Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. Serial Numbers: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B379048 B379643 B380200 B380800 B377193 B377480 B377880 B378945 B379062 B379645 B380206 B380801 B377194 B377481 B377883 B378946 B379063 B379646 B380208 B380803 B377195 B377482 B377885 B378947 B379066 B379650 B380214 B380807 B377196 B377485 B377887 B378949 B379093 B379652 B380227 B380816  ...
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Class II STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. Staar Surgical Co.
Devices Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps. Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464. Class II Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes USA HQ, Inc.
Food QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count "variety pack" case. The affected product has a sell by date of 06/22/13 and a UPC code of 1111039114. Class I The paninis may contain soy and egg, which are allergens. Kroger Co
Food Broccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case. The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74716, Broccoli Salad Kit No Dressing, 3.625lb per case, 6/17/2013. Class I The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Broccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case. The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74717, Broccoli Salad Kit No Dressing No Bacon, 3.375lb per case, 6/17/2013. Class I The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Broccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case. The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74807, Broccoli Salad, 4.04lbs per case, 6/17/2013. Class I The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Sweet & Sassy Apple Salad; packaged in plastic bags inside paper cartons, 5 bags per case. The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74891, Sweet & Sassy Apple Salad, 6.125lbs per case, 6/17/2013. Class I The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which are placed in unmarked brown boxes/cartons. The product has a short shelf life. UPC 0 56931 51125 2 and no other coding Class I Canadian firm recalled Mini Kaiser 10 due to undeclared soy in the product. The product was also found to contain undeclared wheat, sulfites, soybean oil and gluten (barley and/or rye) all from the Doughmaster 200 raw material. Sani Fresh Distribution
Food Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062 Lot #: 11/15/2014 M1, UPC #:1 86852 00039 6 Class II Product contains undeclared Allergen; Pecans. Talenti Gelato
Devices Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907. Class II During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail. Siemens Medical Solutions USA, Inc
Food Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965 BOX UPC: 0 898403 00221 5 (located on the bottom of the box); PACKAGE UPC: 0 898403 00220 8 (located on the rear panel of each package;) SELL BY DATES: FEB061483 and FEB061481. Class I A limited number of packages of 1 ounce Somersault Pacific Sea Salt products were inadvertently mispackaged - Somersault Santa Fe Salsa flavored product were inadvertently commingled with Somersault Pacific Sea Salt flavored product in packages labeled as Somersault Pacific Sea Salt. Somersault Snack Co., LLC
Drugs Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111. Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 Class II Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc
Drugs Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211. Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 Class II Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc
Drugs Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311. Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 Class II Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc
Drugs Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411. Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 Class II Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc
Drugs Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511. Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 Class II Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc
Devices LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations. List Number: 19666-04-28; Lot Number: 87-188-5H Class II Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set. Hospira Inc.
Devices TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) All TDHistology/Cytology product versions. Class III A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and this could potentially lead to the wrong conversion of symbols less than or equal to or greater than or equal to into "=". Technidata S.A.
Devices Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle. Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015 Class II Lancets were not sterilized within the dose range established by sterilization validation. KooJoo Trading Company
Devices Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only. Part # 04.315.067 with lot #s 6184270 and/or 22612-04. Class II The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates. Synthes USA HQ, Inc.
Drugs QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01 Lot 122600 Exp. 03/14 Class II Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg. American Health Packaging
Drugs Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin Lot 87100040 Class III Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. Bayer HealthCare Pharmaceuticals Inc.
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