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U.S. Department of Health and Human Services

Enforcement Report - Week of August 21, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced H78161; H78059; H78063; H78066; H79860; H79870; H78113; H79788; H79790; H79791; H79795; H78108; H78060; H79898; H79905 Class III Blood products, manufactured with an extended time outside of refrigeration, were distributed. San Diego Blood Bank
Biologics Red Blood Cells KW66248 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. San Diego Blood Bank
Biologics Red Blood Cells LR07445 Class II Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed. San Diego Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GH46507- part 1;GH46507- part 2 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced LF32302- part 1;LF32302- part 2 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Tri-Counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced C76634 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. San Diego Blood Bank
Biologics Blood and Blood Products for Reprocessing C76634 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 21KW38284, 21KW38318, 21LG22846, 21LG22848, 21LG22850, 21LG22852, 21LG22862, 21LG22865, 21LH23206, 21LH23222, 21LH23229, 21LH23243, 21LH23280, 21LH23295, 21LH23458, 21LH23461, 21LH23476, 21LH23478, 21LJ18992, 21LJ18996, 21LJ19001, 21LJ19007, 21LJ19014, 21LJ19019, 21LJ19021, 21LJ19036, 21LJ19047, 21LJ19054, 21LJ19061, 21LJ19076, 21LJ19088, 21LJ19100, 21LJ19103, 21LJ19107, 21LJ19112, 21LJ19116, 21LJ19120, 21LJ19124, 21LJ19129, 21LJ19131, 21LJ19134, 21LJI8974, 21LJI8981, 21LJI8998, 21Y94408, 21Y94427, 21Y94442. Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF, Pooled 21KW38284, 21KW38305, 21KW38318, 21LJ19103, 21LJ19112. Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF 21LG22862, 21LJ19047, 21LJ19100 Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Platelet Pheresis Leukocytes Reduced LF41291 Class II Blood product, with a low platelet count, was distributed. Tri-Counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced GW70745; GW52751 Class II Blood products, collected from a donor who was taking the medication Avodart (Dutasteride), were distributed. Tri-Counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GW70745; GW60775, GW52751 Class II Blood products, collected from a donor who was taking the medication Avodart (Dutasteride), were distributed. Tri-Counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 4082244; 4082256(A); 4082319(B); 4082319; 4082366(B); 4082403(A). Class II Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Pheresis 4082256(B); 4082292(A); 4082292(B); 4082311; 4082341(A); 4082341(B); 4082349; 4082361; 4082366(A); 4082374; 4082403(B); 4082423; 4082444(A); 4082444(B) Class II Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 4081978; 4081995 Class II Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) GJ23410 Class III Blood products, leukoreduced more than five days after collection, were distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced FM38468; KW69582 Class III Blood products, leukoreduced more than five days after collection, were distributed. San Diego Blood Bank
Biologics Platelets GG09133; GG09134; GG09139; GG09141; GG09142; GG09144; GG09146; GG09147; GG09148; GG09150; GG09151; GG09153; GG09156; GG09157; GG09159; GG09161; GG09162; GG09164; GG09166; GG09168; GG09172; GG09174; GG09175; GG09177; GG09178; GG09182; GG09185; GG09187; GG09188; GG09189; GG09190; GG09191; GG09192; GG09193; GG09194; GG09195; GG09196; GG09197; GG09314; GG09316; GG09317; GG09320; GG09321; GG09324; GG09325; GG09334; GG09336; GG09338; GG09342; GG09346; GG09347;  ...
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Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced E16324; E16324; E16325; E16325; E16510; E16510; E16910; E16910; E18484; E18484; E18486; E18486; E18488; E18488; GC05347; GC05348; GC05349; GC05350; GC05351; GC05352; GC05401; GC05402; GC05403; GC05404; GC05406; GC05407; GC05408; GC05409; GC05410; GC05411; GC05414; GC05415; GC05416; GC05417; GC05418; GC05419; GC05420; GC05421; GC05423; GC05429; GC05430; GC05432; GE20556; GE20557; GE20558; GE20559; GE20560; GE20561; GE20562; GE20563; GE20564;  ...
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Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced Irradiated GM11056 Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced KN03064; KN03065; KN03066; KN03067; KT04459; KT04460; KT04461; KT04462; KT04463; KT04464; KT04466; KT04466; KT04467; KT04468; KT04468; KT04469; KT04471; KT04471; KT04472; KW04221; KW04222; KW04222; KW04224; KW04224 Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing GC05417; GE20556; GE20557; GE20558; GE20559; GE20560; GE20561; GE20562; GE20563; GE20564; GE20566; GE20567; GE20568; GE20569; GE20570; GE20571; GE20578; GG07989 GG07990; GG07991; GG07992; GG07994; GG09135; GG09136; GG09139; GG09145; GG09148; GG09150; GG09152; GG09154; GG09156; GG09158; GG09159; GG09160; GG09163; GG09166; GG09167; GG09168; GG09169; GG09170; GG09172; GG09173; GG09174; GG09175; GG09176; GG09177; GG09178; GG09179; GG09180; GG09181; GG09182;  ...
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Class III Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Cryoprecipitated AHF GC05347; GC05348; GC05349; GC05350; GC05351; GC05352; GC05401; GC05402; GC05403; GC05404; GC05405; GC05406; GC05407; GC05408; GC05409; GC05410; GC05411; GC05412; GC05413; GC05414; GC05415; GC05416; GC05418; GC05419; GC05420; GC05421; GC05422; GC05423; GC05429; GC05430; GC05431; GC05432; GE20573; GE20574; GE20575; GG07993; GG07995; GG07997; GG07998; GG08000; GK07131; GK07133; GK07134; GK07135; GK07136; GK07139; GK07142; GK07143; GK07150; GK07151;GK07152; GK07154;  ...
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Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Fresh Frozen Plasma GE20577; GG09133; GG09134; GG09141; GG09142; GG09144; GG09146; GG09147; GG09151; GG09153; GG09155; GG09157; GG09161; GG09162; GG09164; GG09165; GG09187; GG09188; GG09197; GG09314; GG09325; GG09336; GG09338; GG09342; GG09347; GK07132; GK07137; GK07138; GK09308; GK09319; GK09326; GK09327; GK09332; GR12397; J58978; J58989; Z20985 ;Z22605; Z22606; Z22607; Z22608; Z22630; Z22631; Z22638; Z22639 Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Irradiated KT04460; KT04463; KT04464; KT04465; KT04467; KW04221; KW04222; KW04223; KW04223; KW04225; KW04225 Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells GC05405; GC05412; GC05413; GC05422; GC05431; GG09136; GG09137; GG09141; GG09164; GG09323; GG09328; GG09329; GG09333; GG09335; GG09343; GH03777; GK07134; GK07143; GK07154; GK07157; GK07158; GK09306; GK09310 ;GK09311; GK09314; GK09316; GK09325; GM10761; GM10932; GM11012; GM11013; GM11016; GM11017; GM11021; GM11026; GM11042; GM11047; GM11084; GM11233; GM11245; GM11248; GM11259; GM11290; GM11356; GM11359; GM11368; GR11123; GR11130; GR11133; GR11134; GR11136  ...
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Class II Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced 21LE11513, 21KM70B40, 21GV22033, 21GV22057, 21GV22058, 21GV22063, 21GV22065, 21GV22066, 21GV22067, 21GV22080, 21GV22094, 21GV22102, 21GV22129, 21GV22133, 21GV22135, 21GV22143, 21GV22144, 21GV22145, 21GV22319, 21GV22341, 21GV22351, 21GV22542, 21GV22550, 21GV22553, 21GV22558, 21GV22574, 21GV22580, 21GV22587, 21GV22588, 21GV22760, 21GV22843, 21GV22844, 21GV22849, 21GV22856, 21GV22872, 21GV22883, 21GV22884, 21GV22893, 21GV23053, 21GV23082, 21GV23119, 21GV23127, 21GV23136, 21GV23138, 21GV23307, 21GV23326, 21GV23335, 21GV23338, 21GV23342, 21GV23350,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Plasma Frozen 21FL94470, 21FL94476, 21FL94481, 21FL94490, 21FL94526, 21FL94529, 21FL94534, 21FL94543, 21FL94555, 21FL94565, 21FL94566, 21FV05688, 21FV05777, 21FV05790, 21FV05861, 21FV05877, 21FV05897, 21GV22038, 21GV22057, 21GV22065, 21GV22074, 21GV22085, 21GV22095, 21GV22106, 21GV22116, 21GV22252, 21GV22265, 21GV22284, 21GV22303, 21GV22305, 21GV22307, 21GV22312, 21GV22341, 21GV22343, 21GV22347, 21GV22349, 21GV22351, 21GV22358, 21GV22363, 21GV22367, 21GV22382, 21GV22406, 21GV22430, 21GV22665, 21GV22757, 21GV22996, 21GV23001, 21GV23009, 21GV23023, 21GV23033,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF 21LC39433, 21LC39436, 21LC39439, 21LC39442, 21LC39444, 21LC39453, 21LC39455, 21LC39456, 21LC39458, 21LC39468, 21LC39469, 21LC39470, 21LC39474, 21LC39477, 21LC39479, 21LC39482, 21LC39486, 21LC39489, 21LC39496, 21LC39499, 21LC39502, 21LC39510. Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Red Blood Cells 21GV32332, 21GV21927, 21GV21928, 21GV21932, 21GV21934, 21GV21952, 21GV21957, 21GV21959, 21GV21961, 21GV21965, 21GV21973, 21GV21976, 21GV21978, 21GV21983, 21GV22038, 21GV22050, 21GV22054, 21GV22074, 21GV22076, 21GV22085, 21GV22092, 21GV22095, 21GV22097, 21GV22099, 21GV22105, 21GV22106, 21GV22116, 21GV22117, 21GV22242, 21GV22245, 21GV22247, 21GV22250, 21GV22252, 21GV22254, 21GV22262, 21GV22264, 21GV22265, 21GV22267, 21GV22269, 21GV22272, 21GV22274, 21GV22276, 21GV22280, 21GV22281, 21GV22284, 21GV22288, 21GV22289, 21GV22294, 21GV22299, 21GV22332,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Red Blood Cells Washed 21KM69651 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Cryoprecipitate AHF, Pooled 21LC39493; 21LC39497 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Irradiated 21FV05867, 21GV22060, 21GV22326, 21GV23122, 21GV25436, 21GV25453, 21GV25696, 21GV28849, 21GV28873, 21GV31557, 21GV31597, 21GV33315, 21KF47698, 21KM65687, 21KM65713, 21KM65751, 21KM66090, 21KM66112, 21KM66775, 21KM67062, 21KM67113, 21KM67214, 21KM67991, 21KM69221, 21KM69232, 21KM70431, 21KM70813, 21KM70839, 21KM71168, 21KM71179, 21KM73336, 21KM74436, 21KM74441, 21KM74458, 21LC39479, 21LC39518, 21LC39542, 21LC39571, 21N 17117, 21N 17698. Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Plasma Frozen Cryoprecipitated Reduced 21LC39439, 21LC39442, 21LC39444, 21LC39458, 21LC39474, 21LC39477, 21LC39482, 21LC39486, 21LC39489, 21LC39499. Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Red Blood Cells 00P64464 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Red Blood Cells 3593908 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Platelets 01KF87789; 01KF89027; 01KF91944; 01KF92867; 01KF93961; 01KF95240; 01KF84002; 01KF81650; 01KF79712 Class II Blood products, in which donor incorrectly identified on deferral list and should have been previously deferred due to testing, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 01KF91944; 01KF92867; 01KX59077 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01KF87789; 01KF89027; 01KF91944; 01KF92867; 01KF93961; 01KF86154; 01KF84002; 01KF81650; 01KF79712; 01KF75395; 01KX59077; 01KF86154; 01KF84002; 01KF81650; 01KF79712; 01KF75395; 01KX59077 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 01KF87789; 01KF89027; 01KF93961; 01KF84002; 01KF79712; 01KF75395 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 01KF95240 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01KF95240; 01KF86154; 01KF81650 Class III Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced LT29798-part 1;LT29798-part 2 Class II Blood products, collected using manufacturer collection kit greater than 24 hours, were distributed. Tri-counties Blood Bank
Biologics Blood and Blood Products for Reprocessing 01E91070 Class III Blood products, in which donor screening and records were incomplete or incorrect and, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01E91070 Class II Blood products, in which donor screening and records were incomplete or incorrect and, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 6856986; 6860461; 6861215; 6865547; 6854661; 6842690; 6857040; 6856333; 6862806; 6862820; 6862823; 6862826; 6864736; 6857712; 6857728; 6857683; 6857716; 6857973; 6868355; 6864305; 6864360; 6860658; 6865286; 6865301; 6864300; 6868319; 6868328 Class III Blood products, stored at unacceptable storage temperatures, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6865366; 6865369 Class III Blood products, stored at unacceptable storage temperatures, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 01KG98036 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01KG98036 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. American National Red Cross (The)
Biologics Source Plasma 369064209, 369063313, 369058837, 369055711, 369052861, 369049176, 369046178, 369044704, 369044083, 369043645, 369042531, 369038854, 369038538, 369035560, 369034111, 369033744, 369031692, 369030018, 369062633, 369058303, 369057991, 369056564, 369055199, 369054911, 369051175, 369049864, 369048936, 369044066, 369043558, 369043059, 369041724, 369037201, 369036706, 369035761, 369032590, 369032117, 369030772, 369063814, 369062548, 369059113, 369053363, 369047074, 369044580, 369039010, 369033116, 369031011, 369061941, 369058142, 369055445, 369054882,  ...
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Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced 1126574, 0879913, 1055017, 0972344 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 1126574, 0972344, 0879913 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Platelets Leukocytes Reduced 1126574, 1055017, 0972344 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 3690046017, 3690047003, 3690057931, 3690070728, 3690069818, 3690071518, 3690075705, 3690082581, 3690084154, 3690084809, 3690086162, 3690086842, 3690087453, 3690088534, 3690089005, 3690090037, 3690122859, 3690110536, 3690113457, 3690117277, 3690069540, 3690076389, 3690077820, 3690079367, 3690082418, 3690084984, 3690085708, 3690086985, 3690087785, 3690094194, 3690095267, 3690097091, 3690101413, 3690101816, 3690110723, 3690110975, 3690116507, 3690121658, 3690122080, 3690127086, 3690129095, 3690085440, 3690087050, 3690087465, 3690088098, 3690089703, 3690084731, 3690085090, 3690095618, 3690071741,  ...
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Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Devices CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation. CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541). Class II Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II. Veridex, LLC
Devices CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data. CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555). Class II Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II. Veridex, LLC
Devices Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit. Lot 260745, exp. 5/31/2014 Class III Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. Remel Inc
Drugs Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Drugs Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA All lots within expiry Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Pallimed Solutions
Food Bulk tablet label: Keytabs W.O. Glandulars (pink) Lot 103-0313 Class II Product contains higher levels of niacin than claimed on label . Ancient Formulas Inc
Food KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO. Lot YDBI, Exp. 03/2016 Class II Product contains higher levels of niacin than claimed on label . Ancient Formulas Inc
Drugs 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 Lot 11215-05,11216-05, 11216-06, 11217-05 Class II CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. Total Resources Intl
Drugs Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789 Lot 11214-07 Class II CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. Total Resources Intl
Drugs (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789 Item Number 20-HBC-01015CCREV1. Class II CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. Total Resources Intl
Devices Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system. Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Numbers: 7197.024, 011649, 011498; Invue Lid: SI70095A, Lot Number: 6250.009-R; S-Lift Lid: SI50070A, Lot Number: 7201.008; S-Lift Base: SI50067A; Lot Numbers: 7183.007R, 7201.007; Arena-C Lid: 11-72013D, 11-72014D, Lot Numbers: 011969-001, 011969-002; Generics Lid: 12-99005A, Lot Number: 8372.001. Class II Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles. SpineFrontier, Inc.
Devices 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation 1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2)  ...
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Class II CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk. Carefusion 2200 Inc
Devices GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications. Serial # 1028082 00000102856WK4 00001027044WK5 00001027046WK0 00001027160WK9 00001027162WK5 00001027164WK1 00001027174WK0 00001027446WK2 00001027449WK6 00001027526WK1 00001027570WK9 00001027739WK0 00001027881WK0 00001027897WK6 00001027900WK8 00001027901WK6 00001027902WK4 00001027903WK2 00001027904WK0 00001027942WK0 00001028045WK1 00001028046WK9 00001028047WK7 00001028048WK5 00001028063WK4 00001028082WK4 00001028219WK2 00001028300WK0 00001028301WK8 00001028304WK2 00001028454WK5 00001028460WK2 00001028461WK0 00001028564WK1 00001028590WK6 00001028591WK4 00001028592WK2 00001028593WK0 00001028594WK8 00001028616WK9 00001028648WK2 00001028649WK0 00001028650WK8 00001028651WK6 00001028653WK2 00001028655WK7 00001028656WK5  ...
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Class II GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance. GE Healthcare, LLC
Devices Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. Lot Number: 011836-0001, 011981-001 Class II The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. SpineFrontier, Inc.
Devices Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510 Class II A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted. Biomet 3i, LLC
Devices Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513 Class II A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted. Biomet 3i, LLC
Devices epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. LOT #'s EXP. DATES 07-12283-00 03/26/2013 07-12284-00 03/27/2013 07-12285-00 03/28/2013 07-12289-00 04/01/2013 07-12290-00 04/02/2013 07-12292-00 04/04/2013 07-12293-00 04/05/2013 07-12296-00 04/08/2013 07-12297-00 04/09/2013 07-12298-00 04/10/2013 07-12300-00 04/12/2013 07-12303-00 04/15/2013 07-12305-00 04/17/2013 07-12306-00 04/18/2013 07-12307-00 04/19/2013 07-12310-00 04/22/2013 07-12312-00 04/24/2013 07-12313-00 04/25/2013 07-12314-00 04/26/2013 07-12317-00 04/29/2013 07-12320-00 05/02/2013 07-12321-00 05/03/2013 07-12324-00 05/06/2013 07-12325-00 05/07/2013 07-12327-00 05/09/2013 07-12331-00 05/13/2013 07-12333-00 05/15/2013 07-12335-00 05/17/2013 07-12338-00 05/20/2013 07-12340-00 05/22/2013 07-12341-00 05/23/2013 07-12345-00 05/27/2013 07-12346-00 05/28/2013 07-12347-00 05/29/2013 07-12349-00 05/31/2013 07-12352-00 06/03/2013 07-12354-00 06/05/2013 07-12355-00 06/06/2013 07-12362-00 06/13/2013 07-12363-00 06/14/2013 07-13002-00 06/19/2013 07-13003-00 06/20/2013 07-13004-00 06/21/2013 07-13007-00 06/24/2013 07-13008-00 06/25/2013 07-13009-00 06/26/2013 07-13010-00  ...
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Class II This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range. Epocal
Devices SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808" Mfg Lot or Serial # 00000298045MR6 00000237944MR4 00000278301MR7 00000257724MR5 00000029079MR2 00000280678MR4  ...
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Class II Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems. GE Healthcare, LLC
Food IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS. Lot: 12173, 12305 and 13065. Class II The product contains Soy Protein Isolate which may be contaminated with Salmonella. C H S Inc
Devices GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. GSI Viewer on CT750HD CT Systems  Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6 00000419816CN4 00000408127CN9 00000408230CN1 00000409450CN4 00000412501CN9 00000411125CN8 00000409344CN9 00000409145CN0 00000412398CN0 00000409881CN0 00000413835CN0 00000413765CN9 00000411126CN6 00000412015CN0 00000412399CN8 00000411349CN4 00000411611CN7 00000414853CN2 00000415105CN6 00000416839CN9 00000416410CN9 00000409806CN7 00000414686CN6 00000420612CN4 00000421374CN0 00000411613CN3 00000415502CN4 00000412042CN4 00000414971CN2 00000413841CN8 00000413362CN5 00000413566CN1 00000420173CN7 00000412503CN5 00000415396CN1 00000415826CN7 00000421147CN0 00000414851CN6 00000415104CN9 00000419891CN7 00000420174CN5 00000414852CN4 00000414973CN8 00000416765CN6 00000418112CN9 00000418335CN6 00000420610CN8 00000416669CN0 00000415439CN9 00000416628CN6 00000417737CN4 00000415469CN6 00000417465CN2 00000419582CN2 00000421590CN1 00000418155CN8 00000417172CN4 00000418484CN2 00000419819CN8 00000418156CN6 00000421378CN1 00000419107CN8 00000422266CN7 00000421121CN5 00000419817CN2 00000422267CN5 00000411391CN6 00000416872CN0 00000417476CN9 00000419135CN9 00000419447CN8 00000408673CN2 00000411348CN6 00000409754CN9 00000409805CN9 00000412738CN7 00000416033CN9 00000416779CN7 00000416974CN4 00000417373CN8 00000409751CN5 00000409343CN1 00000409755CN6 00000409807CN5 00000409753CN1 00000417769CN7 00000414972CN0 00000415092CN6 00000414879CN7 00000416546CN0 00000416122CN0 00000416037CN0 00000419954CN3 00000418659CN9 00000416943CN9 00000417766CN3 00000409879CN4 00000415358CN1 00000413323CN7 00000415204CN7 00000415203CN9 00000417806CN7 00000415448CN0 00000415240CN1 00000414058CN8 00000417618CN6 00000416588CN2 00000416366CN3 00000416545CN2 00000417422CN3 00000418021CN2 00000418154CN1 00000418033CN7 00000421065CN4 00000419773CN7 00000419732CN3 00000417222CN7 00000421290CN8 00000419890CN9 00000409160CN9 00000416309CN3 00000416034CN7 00000420866CN6 00000414878CN9 00000418469CN3 00000409575CN8 00000409880CN2 00000409877CN8 00000411339CN5 00000413307CN0 00000414106CN5 00000412737CN9 00000414912CN6 00000416121CN2 00000409808CN3 00000416766CN4 00000417736CN6 00000418032CN9 00000418822CN3 00000418002CN2 00000417871CN1 00000420868CN2 00000420387CN3 00000421730CN3 00000412739CN5 00000412804CN7 00000414854CN0 00000417329CN0 00000417645CN9 00000412502CN7 00000405726CN1 00000416788CN8 00000409878CN6 00000418304CN2 00000407781CN4 00000418983CN3 00000419136CN7 00000411639CN8 00000414788CN0 00000414748CN4 00000413967CN1 00000416375CN4 00000419703CN4 00000409159CN1 00000407937CN2 00000411566CN3 00000413324CN5 00000409451CN2 00000414582CN7 00000415411CN8 00000409408CN2 00000414657CN7 00000415835CN8 00000415387CN0 00000416522CN1 00000416619CN5 00000416871CN2 00000417087CN4 00000417330CN8 00000417765CN5 00000416978CN5 00000418279CN6 00000418176CN4 00000417755CN6 00000418524CN5 00000419777CN8 00000421146CN2 00000421066CN2 00000421232CN0 00000421233CN8 00000421291CN6 00000421148CN8 00000421231CN2 00000421377CN3 00000418700CN1 00000415447CN2 00000417178CN1 00000418149CN1 00000418523CN7 00000420611CN6 00000414057CN0 00000416243CN4 00000420588CN6 00000421063CN9 00000417768CN9 00000411825CN3 00000408320CN0 00000413092CN8 00000417251CN6 00000419133CN4 00000419132CN6 00000421171CN0 00000420613CN2 00000409621CN0 00000415872CN1 00000416032CN1 00000416446CN3 00000418830CN6 00000419704CN2 00000414317CN8 00000418177CN2 00000408437CN2 00000409752CN3 00000414094CN3 00000415957CN0 00000414874CN8 00000416787CN0 00000417487CN6 00000418331CN5 00000420590CN2 00000420426CN9 00000420383CN2 00000420589CN4 Class II GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does not flip S DICOM coordinates when it fills in the DICOM header for tilted images using the Recon Flip/Rotate top-bottom flip (FTB). The images created are stored with an incorrect coordinate value, which incorrectly puts the image in the wrong plane causing the image coordinates annotated on a viewer to be incorrect. GE Healthcare, LLC
Devices IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes. Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121228600200315, 121228600200316 121228600200322, 121228600200323, 121228600200324, 121228600200325, 121228600200326 121228600200332, 121228600200333, 121228600200334, 121228600200335, 121228600200336 121228600200342, 121228600200343, 121228600200344, 121228600200345, 121228600200346 121228600200352, 121228600200353, 121228600200367, 121228600200368, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 121228600200402, 121228600200403, 121228600200404, 121228600200405, 011328600100406 011328600100412, 011328600100413,  ...
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Class II Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubing subassembly. All IsoGel AIR" Support Surfaces come equipped with integrated Low Air Loss (LAL) tubing. Low Air Loss functionality is available only if the surface is connected to the optional Stryker Air Pump. Stryker Medical Division of Stryker Corporation
Devices Terumo® Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment. Catalog number: 801763 Class II The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react. Terumo Cardiovascular Systems Corporation
Devices Terumo® Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment. Catalog number: 801764 Class II The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react. Terumo Cardiovascular Systems Corporation
Devices Carestream DRX Evolution System, X-ray system --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Carestream DRX Evolution System using V5.5.410.33 MR2 Software Class II To a potential for an x-ray exposure technique change. Carestream Health Inc.
Devices 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Catalog number: 801763 Class II TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system. Terumo Cardiovascular Systems Corporation
Devices 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Catalog number: 801764 Class II TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system. Terumo Cardiovascular Systems Corporation
Devices Terumo® Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Catalog Number or Part Number: 801763 Description: 100/120V AC, Advanced Perfusion System 1 Class II Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated. Terumo Cardiovascular Systems Corporation
Devices Terumo® Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1 Class II Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated. Terumo Cardiovascular Systems Corporation
Drugs buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01 The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011. Class III Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds. American Health Packaging
Drugs Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 The affected product consists of lot #261739A, expiration date OCT 2014. Class III Labeling: Missing Label; missing label on blister card Boehringer Ingelheim Roxane Inc
Devices Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System. Serial Numbers: 1) J34000102 through J34002323, 2) 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610,  ...
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Class II Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement. Ortho-Clinical Diagnostics
Devices REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor. 60729528 60720059 60782350 60803204 60811712 60889765 60909408 60943022 60948237 60989841 60985366 61019823 61051119 61034821 61140638 61178017 61207698 61237374 61304005 61338570 61356591 6381187 61400935 61431685 61463330 61487660 61521267 61544005 61585968 61627734 61704564 61735029 61772406 61794587 61817713 61858701 61850103 61877862 61950512 61998686 61972672 62010251 62018071 62041751 62078963 62096387 62121179 62136094 62141873 62158509 62180443 62203390 62215390 62249372 62271566 62298060 Class II There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture. Zimmer, Inc.
Devices REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor. 60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420 Class II There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture. Zimmer, Inc.
Devices Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity. All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115 Class II Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned. Synthes USA HQ, Inc.
Devices 5.0mm Unit steel rod, pedicle screw spinal system. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. ALL LOTS of part numbers 298.269 and 298.278. Lot numbers were listed as: 4729951, 4841209, 4923651, 4923652, 4987688, 4987750, 5350635, 2002330, 3000595, 4729962, 4835378, 4856252, 4919165, 4923660, 4987686, 4987776, 5153851. Class II DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to the patient outside of the current instructions for Use. The firm has not become aware of any impact to the patient due to the finishing found on the stainless steel rods subject to this notice. Synthes USA HQ, Inc.
Devices GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5  ...
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Class II GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measurement) near the edge of the image. As a result the cursor may need to be moved from near the edge of the image area. GE Healthcare, LLC
Drugs Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33 Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013 Class II Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel Hospira Inc.
Devices Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1010211346 12/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020411347 12/31/2013 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020611348 12/31/2013 1020712206 07/31/2014 1020811350 12/31/2013 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1010312046 10/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020712206 07/31/2014 1020811350 12/31/2013 1020912292 10/31/2014 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1020211355 12/31/2013 1020212032 02/28/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213043 02/28/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1020212032 02/28/2014 1020212100 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020213074 03/31/2015 1020412341 12/31/2014 1020912292 10/31/2014 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1020212032 02/28/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 102121304 02/28/2015 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Lot #/Exp.Date: 1020112086 03/31/2014 1020212032 02/28/2014 1020213074 03/31/2015 1020213109 04/30/2015 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Kit Lot/Exp: 1010112004 10/31/2013 1010112038 10/31/2013 1010112109 02/28/2014 1010112121 02/28/2014 1010112159 02/28/2014 1010112228 05/31/2014 1010112289 07/31/2014 1010113016 09/30/2014 1010113052 12/31/2014 1010113134 12/31/2014 1010113177 03/31/2015 1010212046 10/31/2013 1010212109 02/28/2014 1010212121 12/31/2013 1010212143 02/28/2014 1010212206 03/31/2014 1010212228 03/31/2014 1010212289 07/31/2014 1010212354 09/30/2014 1010213016 09/30/2014 1010213052 12/31/2014 1010213134 09/30/2014 1010312016 10/31/2013 1010312025 10/31/2013 1010312046 10/31/2013 1010312095 02/28/2014 1010312121 03/31/2014 1010312171 03/31/2014 1010312180 03/31/2014 1010312207 03/31/2014 1010312228 05/31/2014 1010312262 06/30/2014 1010312289 07/31/2014 1010312312 09/30/2014 1010312354 09/30/2014 1010313016 09/30/2014 1010313052 12/31/2014 1010313101 12/31/2014 1010313128 01/31/2015 1010313134 01/31/2015 1010411355 10/31/2013 1010412016 10/31/2013 1010412046 10/31/2013 1010412066 10/31/2013 1010412093 12/31/2013 1010412095 10/31/2013 1010412121 03/31/2014 1010412262 03/31/2014 1010412312 09/30/2014 1010413101 01/31/2015 1010413134 01/31/2015 1010413171 04/30/2015 1010512016 10/31/2013 1010512095 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control 1020211350 12/31/2013 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control 1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Devices Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control 1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014 Class I Reports of false abnormally high glucose readings from test strips Nova Biomedical Corporation
Food Spartan Fresh Dark Chocolate Covered Dried Cherries 8oz Distributed 6/26/13: UPC code: 0-11213-01592 and lot codes: 021814, 031214, 032714, and 061214. Class II The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries. Shoreline Fruit Inc
Food Cherry Bay Orchards Dark Chocolate Covered Dried Balaton Cherries 4lb, 8oz, and 16oz containers 4 lbs. 8-53955-00004-1 with lot codes: 042314, 060514, and 040914. 8 oz. 8-46659-00007-3 with lot codes: 032714, 042314, 052314, 052914, and 062014. 16 oz. 8-46659-00008-0 with lot codes: 051414 and 040814. Class II The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries. Shoreline Fruit Inc
Food Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries 25lbs Lot code: 012513 Class II The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries. Shoreline Fruit Inc
Devices ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2. REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013 Class III Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. Siemens Healthcare Diagnostics, Inc
Food Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case. Product with a make date of 7-1-13 or prior Class I Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes. Crave Brothers Farmstead Cheese, LLC
Food Crave Brothers Farmstead Classics Petit Frere Soft Ripened Cheese, PF88. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz wheels per case. Product with a make date of 7-1-13 or prior Class I Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes. Crave Brothers Farmstead Cheese, LLC
Food Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz. wheels per case. Product with a make date of 7-1-13 or prior Class I Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes. Crave Brothers Farmstead Cheese, LLC
Devices ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine. Lot No. T006042 Class II Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments. Beckman Coulter Inc.
Veterinary MannaPro Goat Treats, Licorice Flavor, 6 lb bag, Manufactured by: MannaPro, St. Louis, MO. Positive Pellet Goat Dewormer packed in Goat Treat bags packaged in Positive Pellet Goat Dewormer shipping boxes. The Positive Pellet Goat Dewormer contains 880 gram Morantel Tartrate per ton. "MADE K 06/01/13" Class III Positive Pellet goat dewormer (medicated) is packaged in Goat Treats bags. Manna Pro Corp
Devices C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies. Product lines with lot number 10405513 and higher Class II Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Atrium Medical Corporation
Devices C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Product lines with lot number 10405513 and higher Class II Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Atrium Medical Corporation
Devices C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Product lines with lot number 10405513 and higher Class II Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Atrium Medical Corporation
Devices C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Product lines with lot number 10405513 and higher Class II Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Atrium Medical Corporation
Food "***Gasco Golden Egg Yellow Shade Liquid***" 32 oz plastic bottles & 15 gallon drums 080812, 110912, 051112, 220413 Class II Undeclared allergens: Yellow #5 Gasco Industrial
Devices Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539. Class II Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments. Siemens Medical Solutions USA, Inc
Devices Siemens AXIOM Artis zeego x-ray, angiographic system Model number 10280959 Class II Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system. Siemens Medical Solutions USA, Inc
Devices Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface. Lot Numbers: 12635577 and 12637041 Class II Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death. Medtronic Inc. Cardiac Rhythm Disease Management
Devices StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action. Class II Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use. Medtronic Navigation, Inc.
Devices Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly. Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708 Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763 Class II Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device. Edwards Lifesciences, LLC
Food Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708. expiration date BEFORE 8/31/13 Class III Walong Marketing is recalling SunFlower Seeds because it may contain undeclared sulfites. Walong Marketing, Inc.
Food individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as " Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY". Expiration dates 12/1/13 and 1/13/14. Class II A recall was initiated as a result of an undeclared sugar ingredient in the labeling used for Jennies' Dutch Chocolate Macaroons. Red Mill Farms
Food Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC Lot: 20130418 Class I One lot of Brach's Chocolate Malted Milk Balls may contain undeclared chocolate covered peanuts and brazil nuts. Ferrara Candy Company
Food FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated UPC: 4607095500208; best by dates 5/15/2013 and 7/17/2013 Class I The product was found to contain Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets. Zip International Group LLC.
Drugs Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons. Batch/Lot 619442, exp. 01/2015 Class III Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP Hi-Tech Pharmacal Co., Inc.
Food Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109 Flour tortillas packaged with corn tortilla label on 07/24/13. Class II The product is being recalled for undeclared wheat. The flour tortillas were mislabeled as corn tortillas. Tortilleria Lupita, Inc.
Food RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package. Expiration Date 103113 (stamped on the back of the package) Class I The product was found to be contaminated with Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets. Gold Star Smoked Fish Corp.
Food Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04812-0; UPC Bottle: 7-02770-24810-0; PDCN code: CAA12. Products packaged on or before May 15, 2013. Individual bottle does not have any codes. Class III Square Mile Original Hard Apple Cider is recalled because bottles may burst. Craft Brewers Alliance Inc.
Food Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04912-0 UPC Bottle: 7-02770-24910-0 PDCN code: CAB12 Products packaged on or before May 15, 2013. Individual bottle does not have any codes. Class III Square Mile Spur & Vine Hopped Apple Cider is recalled because bottles may burst. Craft Brewers Alliance Inc.
Devices Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient. Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08. Class II The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure. Fisher Scientific Co
Devices 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. LOT 91300335 - Catalogue Number 01-1050-0002 Class II OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has the correct etched size, part number and lot number on it. OrthoPediatrics Corp
Devices Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. Catalog # AK-17702-CDC, lot # RF2083258 Class II Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. Arrow International Inc
Devices Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures. ALL Lots of the following models: Model 3717000 = 2 Level Instrument  ...
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Class II The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY" Medtronic Xomed, Inc.
Devices Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30. Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512  ...
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Class II Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. Edwards Lifesciences, LLC
Drugs Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724. 1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015. Class II Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets West-Ward Pharmaceutical Corp.
Devices Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring. GE product number M1024229 Class II GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe nasally which may result in epistaxis (nosebleed). Epistaxis can vary in severity and include severe bleeding that may require specialty (otolaryngology) care. Vital Signs Devices, a GE Healthcare Company
Drugs Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40 Lot # 00500512, Exp. 11/15 Class II Presence of foreign substance: One lot of the product may contain black foreign particles Bracco Diagnostics Inc
Drugs Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34 a)Lot: 5055822, exp. 03/13; 5056317, exp. 03/15; and 5056507, exp. 04/15 b)Lot: 7956571C, exp. 04/15 c)Lot: 7956572A, exp. 04/15 Class II Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp. Dr. Reddy's Laboratories, Inc.
Drugs REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8. Lot #: 02313325GAB4LN1 and 02313325GAB3LN1, Exp 01/23/15 Class II Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea. Showline Automotive Products, Inc. dba US Soaps Mfg. Company
Drugs Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887 Lot # 3099036, Exp 03/2014 Class II Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment. Sanofi-Synthelabo
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