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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117. Class II Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life. Advanced Sterilization Products
Biologics Red Blood Cells Leukocytes Reduced Unit # 7162431 Class III Blood products, for which donor's whole blood unit was screened for hemoglobin utilizing the hemocue was not quality controlled, was distributed. New York Blood Center, Inc.
Biologics Red Blood Cells 4509212, 4509442, 4509478, 4509605, 4509696, 4509805, 4510024, 4510090, 4510106, 4510132, 4510164, 4510177, 4510447, 4510488, 4510588, 4510940, 4511365, 4511467, 4511575, 4511757, 4511817, 4512262, 4512463, 4512867, 4512909, 4513438, 4513646, 4513777, 4514154, 4514814, 4515587, 4515632, 4518110, 4520848, 5508255, 5508770, 5508851, 5509004, 5509487, 5509648, 5509928, 5510214, 5510239, 5510915, 5511767, 5511838, 5512680, 4517732, 4526960, 4534465, 4536300, 5519447, 4505205, 4505609, 4506269, 4506432, 4507505, 4507712, 4508580, 5502890, 5503010, 5503070, 5503368, 5503796, 5503926, 5505119, 5505217, 5505534, 5505623, 5505877, 5505996, 5506299, 5506349, 5506350, 5506581, 5506839, 5506852, 5507042, 5507782, 5507898, 5508055, 5508223, 5508677, 5508737 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 5523111, 5523111, 4509534, 4512975, 4515077, 4515182, 4515903, 4516052, 4516095, 4516161, 4516568, 4516729, 4519211, 4519255, 4519381, 4519587, 4519812, 4520674, 5512187, 5512343, 5512542, 5513003, 5513120, 5513141, 5515307, 5515497, 5515980, 5516634, 5516643, 5516647, 5517146, 5517324, 4503210, 4517361, 4517486, 4521445, 4524499, 4524530, 4524695, 4525274, 4525392, 4525894, 4526651, 4526750, 4527024, 4527032, 4527375, 4527402, 4527735, 4527793, 4528165, 4528210, 4528318, 4528427, 4528621, 4528674, 4528756, 4528771, 4529623, 4529759, 4530146, 4530170, 4530176, 4530660, 4531509, 4531960, 4532232, 4532297, 4533447, 4533528, 4533547, 4534603, 4535112, 4536584, 4536744, 4538230, 4538258, 4538687, 4539147, 4540392, 4540707, 4540746, 4541404, 4543435, 5514406, 5517736, 5518206, 5518212, 5518981, 5519879, 5519882, 5520083, 5520339, 5520755, 5521289, 5522042, 5522874, 5523087, 5523191, 5523319, 5523379, 5523846, 5524053, 5524079, 5524100, 5524837, 5525075, 5525714, 5526462, 5526510, 5527024, 5527507, 5527588, 5527751, 5528692, 5528942, 5529724, 5531070, 6501366, 6501857, 6502434, 6503078, 6503108, 6503146, 6503147, 6503167, 6503444, 6504576 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Cryoprecipitated AHF 4503210, 4507505, 4512262, 4512867, 4514814, 4515182, 4515587, 4518110, 4519381, 4521445, 4524695, 4526651, 4527024, 4527375, 4527402, 4527793, 4528427, 4528621, 4528674, 4528756, 4528771, 4529623, 4529759, 4530146, 4530660, 4531509, 4533447, 4533528, 4533547, 4534603, 4535112, 4536300, 4536584, 4536744, 4538230, 4538258, 4538687, 4539147, 4540392, 4540707, 4540746, 4541404, 4541841, 5515497, 5516643, 5516647, 5517146, 5517324, 5519447, 5520083, 5523075, 5523087, 5523111, 5523319, 5523379, 5524079, 5526510, 5528942, 5529724, 5531070, 6501366, 6501857, 6503167, 6504576, 4507936, 4512975, 5512343 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Plasma 4505652, 4507702 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Whole Blood 4505924, 4527043, 4527164, 4515076 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Fresh Frozen Plasma 4507646, 4508628, 4510588, 4511817, 4513438, 4516568, 4520674, 4524499, 4524530, 4527032, 4528165, 4528210, 4528318, 4530176, 4531960, 4532232, 4532297, 5518981, 5519879, 5522874, 5523846, 5524100, 5525075, 5525714, 5527024, 5527507, 6502434, 6503146, 6503147, 4510294, 4531492, 4520127, 4530283, 4538221, 4530571 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated 5509654, 4541841, 5523075 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced 4530571 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Platelets 4505205, 4505609, 4506269, 4506432, 4508580, 4509534, 4509696, 4510090, 4510106, 4510132, 4510447, 4510940, 4511365, 4511575, 4511757, 4511817, 4512463, 4513646, 4514154, 4515077, 4515903, 4516052, 4516161, 4516729, 4517361, 4517486, 4519211, 4519812, 4520674, 4524530, 4525274, 4525392, 4527735, 4528210, 4528318, 4543435, 5503010, 5503070,5503368, 5505217, 5505534, 5505623, 5505996, 5508223, 5509487, 5510915, 5512680, 5514406, 5516634, 5518026, 5518212, 5520339, 5522042, 5522874, 4507712 Class II Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed. Northern California Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 06GQ23679 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 2268768, 2266307A, 2256611, 2271023, 2256594, 2261965, 2264412, 2266496, 2247581 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Central Kentucky Blood Center, Inc.
Biologics Red Blood Cells 006FP55966; 006FP55967; 006FP55969; 006FP55970 Class III Blood products, labeled with the incorrect expiration date, were distributed. American National Red Cross (The)
Biologics Source Plasma 4090207495, 4090205675, 4090204264, 4090235520, 4090233769, 4090232778, 4090230841, 4090229972, 4090228164, 4090226516, 4090225586, 4090216820, 4090215970, 4090214383, 4090213727, 4090210202, 4090209066 Class II Blood products, collected from a donor who did not have a physical examination, were distributed. ZLB Bioplasma, Inc.
Biologics Cornea SA200801181, SA200801182 Class II Corneas, recovered from a donor who had not been properly evaluated for hemodilution, were distributed. San Antonio Eye Bank
Food Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz. Lot numbers CM120621 through CM121241. Class II The recall was initiated because the Almond Truffle flavoring used in the manufacturing of the recalled product contains a small percentage of whey, a milk derivative. Cafe Moto
Biologics Cornea for human transplant 2009076029 and 2009076030 Class II Human Cornea, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Heartland Lions Eye Bank
Food Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:"***Nestle Nesquick Chocolate FLAVOR*** NET WT***48.7OZ***DISTRIBUTED BY***NESTLE USA, INC., GLENDALE, CA 91203 USA***". Recalled product under following Batch number: 210458802G, 210558802G, 210758803G, 210658801g, 210658801G. Code Date Breakdown: 2-Year code (2012) 104-Julian code 5880-plant code 2-shift G-line designation Class III Firm initiated recall due to potential contamination with metal fragments. Nestle USA
Biologics Red Blood Cells Leukocytes Reduced W128710103915 Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Delta Blood Bank
Biologics Red Blood Cells W051511030223; W051511005040; W051511004139; W051511004138; Class II Blood products, for which testing for hepatitis B surface antigen was invalid, were distributed. Memorial Blood Centers
Biologics Tendon products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label. Graft ID#s B100123001; B100123002; B100123007; B100123008; B100123009; B100123010; B100124001; B100124002; B100124003; B100124005; B100124006; B100124007; B100124008; B100124011; B100124012; B100124013; B100125003; B100125004; B100126001; B100126002; B100126006; B100126014; B100127002; B100127003; B100127004; B100141001; B100141006; B100141007; B100141008; B100141009; B100141012; B100141013; B100141014; B100141015; B100141016; B100141017; B100142001; B100142002; B100142003; B100142005; B100142006; B100142011; B100142012; B100142013; B100145007; B100145008; B100152001; B100152002; B100152007; B100153001; B100153005; B100153006; B100155001; B100155004; B100155005; B100159002; B100159003; B100159004; B100159007; B100187001; B100187002; B100187007; B100187008; B100187009; B100187010; B100187012; B100187013; B100187014; B100188006; B100188009; B110002001; B110002002; B110002003; B110002004; B110002007; B110002008; B110002009; B110002010; B110002011; B110002012; B110034001; B110034002; B110043001; B110043009; B110048001; B110048002; B110048005; B110048006; B110048009; B110048010; B110048011; B110048012; B110049005; B110049006; B110049007; B110049011; B110065001; B110065004; and B110091004 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Bacterin International Inc. Biologics Division
Biologics Bone products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label. B100123201; B100123202; B100123203; B100123204; B100123205; B100123206; B100123207; B100123208; B100123209; B100123210; B100123215; B100123217; B100123218; B100123219; B100123220; B100123221; B100123222; B100123223; B100123224; B100123225; B100123226; B100123227; B100123228; B100123229; B100123230; B100123231; B100123232; B100123233; B100123234; B100123235; B100123236; B100123237; B100123238; B100123239; B100123240; B100123241; B100123242; B100123243; B100123244; B100123245; B100123246; B100123271; B100123281; B100123294; B100123295; B100123296; B100123297; B100123298; B100123801; B100123802; B100123803; B100123804; B100123805; B100123806; B100123808; B100123809; B100123812; B100123813; B100123814; B100123815; B100123816; B100123817; B100123818; B100123819; B100123820; B100123821; B100123822; B100123824; B100123825; B100123826; B100123827; B100123828; B100123829; B100123830; B100123831; B100123832; B100123833; B100123834; B100123835; B100123837; B100123839; B100123840; B100123841; B100123843; B100123844; B100123845; B100123846; B100124202; B100124203; B100124204; B100124207; B100124209; B100124211; B100124212; B100124213; B100124214; B100124215; B100124216; B100124217; B100124218; B100124219; B100124220; B100124223; B100124224; B100124225; B100124226; B100124234; B100124235; B100124236; B100124237; B100124238; B100124801; B100124802; B100124803; B100124804; B100124805; B100124807; B100124808; B100124810; B100124811; B100124812; B100124813; B100124814; B100124815; B100124816; B100124817; B100124818; B100124823; B100124824; B100124825; B100124826; B100124827; B100124828; B100124831; B100124832; B100124833; B100124834; B100124835; B100124836; B100124837; B100124838; B100124839; B100124840; B100124841; B100124842; B100124843; B100124844; B100124845; B100124846; B100124848; B100124849; B100124850; B100124851; B100124852; B100124853; B100124854; B100124855; B100124856; B100124857; B100124858; B100125201; B100125202; B100125203; B100125204; B100125205; B100125206; B100125207; B100125208; B100125209; B100125210; B100125211; B100125212; B100125213; B100125214; B100125215; B100125216; B100125217; B100125218; B100125219; B100125220; B100125221; B100125222; B100125223; B100125224; B100125226; B100125227; B100125228; B100125229; B100125230; B100125231; B100125232; B100125233; B100125234; B100125235; B100125236; B100125237; B100125239; B100125240; B100125241; B100125242; B100125243; B100125244; B100125245; B100125246; B100125247; B100125248; B100125249; B100125250; B100125251; B100125252; B100125253; B100125254; B100125255; B100125256; B100125257; B100125258; B100125259; B100125260; B100125261; B100125262; B100125263; B100125264; B100125265; B100125266; B100125267; B100125268; B100125269; B100125270; B100125271; B100125272; B100125273; B100125274; B100125275; B100125276; B100125277; B100125278; B100125283; B100125284; B100125702; B100125703; B100125704; B100125705; B100125706; B100125708; B100125709; B100125710; B100125712; B100125713; B100125714; B100125715; B100125720; B100125721; B100125723; B100125724; B100125725; B100125726; B100125727; B100125728; B100125729; B100125730; B100125730; B100125731; B100125732; B100125733; B100125734; B100125735; B100125736; B100125737; B100125738; B100125739; B100125740; B100125741; B100125742; B100125743; B100125744; B100125745; B100125746; B100125748; B100125749; B100125750; B100125751; B100125752; B100125753; B100125754; B100125755; B100125756; B100125761; B100125762; B100125763; B100125764; B100125765; B100125766; B100125767; B100125768; B100125769; B100125770; B100125771; B100125773; B100125774; B100125775; B100125776; B100125778; B100125779; B100125781; B100126201; B100126202; B100126203; B100126204; B100126205; B100126206; B100126207; B100126208; B100126209; B100126210; B100126211; B100126212; B100126213; B100126214; B100126215; B100126216; B100126217; B100126218; B100126219; B100126220; B100126221; B100126222; B100126223; B100126224; B100126227; B100126228; B100126229; B100126230; B100126231; B100126232; B100126233; B100126234; B100126235; B100126236; B100126237; B100126241; B100126242; B100126248; B100126249; B100126250; B100126252; B100126253; B100126254; B100126255; B100126256; B100126257; B100126264; B100126265; B100126266; B100126267; B100126269; B100127202; B100127203; B100127204; B100127205; B100127206; B100127207; B100127208; B100127210; B100127211; B100127212; B100127213; B100127214; B100127215; B100127216; B100127217; B100127218; B100127219; B100127220; B100127221; B100127222; B100127223; B100127224; B100127225; B100127226; B100127227; B100127228; B100127229; B100127230; B100127231; B100127232; B100127233; B100127234; B100127235; B100127236; B100127237; B100127238; B100127239; B100127240; B100127241; B100127243; B100127244; B100127245; B100127246; B100127247; B100127248; B100127249; B100127250; B100127251; B100127252; B100127253; B100127254; B100127255; B100127256; B100127257; B100127258; B100127259; B100127260; B100127261; B100127262; B100127263; B100127264; B100127265; B100127266; B100127267; B100127268; B100127269; B100127270; B100127271; B100127272; B100127273; B100127274; B100127275; B100127276; B100127277; B100127278; B100127279; B100127291; B100127292; B100127293; B100127294; B100141210; B100141211; B100141212; B100141214; B100141215; B100141216; B100141217; B100141218; B100141219; B100141220; B100141221; B100141222; B100141223; B100141230; B100141231; B100141234; B100141235; B100141236; B100141237; B100141238; B100141239; B100141240; B100141241; B100141242; B100141243; B100141244; B100141245; B100141246; B100141247; B100141248; B100141249; B100141250; B100141251; B100141253; B100141254; B100141255; B100141256; B100141257; B100141258; B100141260; B100141261; B100141262; B100141263; B100141264; B100141265; B100141266; B100141267; B100141268; B100141269; B100141270; B100141271; B100141272; B100141273; B100141274; B100141275; B100141276; B100141277; B100141278; B100141279; B100141280; B100141281; B100141282; B100141283; B100141284; B100141285; B100141286; B100141287; B100141288; B100141289; B100141290; B100141291; B100141292; B100141293; B100141294; B100141295; B100141296; B100141297; B100141298; B100141299; B100141300; B100141806; B100141808; B100141809; B100141810; B100141811; B100141814; B100141816; B100141817; B100141820; B100141821; B100141822; B100141823; B100141824; B100141826; B100141827; B100141828; B100141846; B100141847; B100141848; B100141849; B100141850; B100141851; B100141852; B100141853; B100141854; B100141855; B100141856; B100141858; B100141859; B100141860; B100141861; B100141862; B100141863; B100141864; B100141865; B100141866; B100141867; B100141868; B100141869; B100141870; B100141871; B100141872; B100141873; B100141874; B100141875; B100141876; B100142101; B100142201; B100142202; B100142203; B100142204; B100142205; B100142206; B100142209; B100142211; B100142212; B100142213; B100142214; B100142215; B100142216; B100142217; B100142218; B100142219; B100142220; B100142221; B100142222; B100142223; B100142224; B100142225; B100142227; B100142228; B100142229; B100142230; B100142231; B100142232; B100142233; B100142234; B100142235; B100142236; B100142237; B100142238; B100142239; B100142240; B100142241; B100142242; B100142243; B100142244; B100142246; B100142247; B100142248; B100142249; B100142250; B100142251; B100142252; B100142253; B100142254; B100142255; B100142256; B100142257; B100142258; B100142259; B100142260; B100142261; B100142262; B100142263; B100142264; B100142265; B100142266; B100142267; B100142268; B100142269; B100142270; B100142271; B100142272; B100142273; B100145215; B100145216; B100145217; B100145218; B100145221; B100145222; B100145223; B100145224; B100145225; B100145226; B100145227; B100145228; B100145230; B100145231; B100145232; B100145233; B100145234; B100145235; B100145236; B100145237; B100145238; B100145239; B100145240; B100145241; B100145242; B100145243; B100145244; B100145245; B100145246; B100145247; B100145248; B100145249; B100145250; B100145251; B100145252; B100145253; B100145254; B100145255; B100145256; B100145257; B100145258; B100145259; B100145260; B100145261; B100145263; B100145264; B100145265; B100145266; B100145267; B100145268; B100145269; B100145270; B100145273; B100145274; B100145275; B100145276; B100145277; B100145278; B100145279; B100145280; B100145281; B100145282; B100145283; B100145284; B100145285; B100145286; B100145287; B100145288; B100145289; B100145290; B100145291; B100145292; B100145293; B100145294; B100145295; B100145296; B100145297; B100145298; B100145299; B100145300; B100145501; B100145502; B100145503; B100145504; B100145505; B100145506; B100145507; B100145508; B100145509; B100145510; B100145801; B100145802; B100145803; B100145805; B100145805; B100145806; B100145807; B100145808; B100145809; B100145810; B100145811; B100145812; B100145813; B100145814; B100145815; B100145817; B100145818; B100145819; B100145820; B100145821; B100145822; B100145823; B100145824; B100145825; B100145826; B100145827; B100145828; B100145829; B100145830; B100145831; B100145832; B100145833; B100145834; B100145835; B100145836; B100145837; B100145838; B100145839; B100145840; B100145841; B100145842; B100145844; B100145845; B100145846; B100145847; B100145848; B100145849; B100145850; B100145851; B100145852; B100145853; B100145854; B100145855; B100145856; B100145857; B100145858; B100145859; B100145861; B100145862; B100145863; B100145865; B100145866; B100145867; B100145868; B100145869; B100145870; B100152101; B100152102; B100152201; B100152202; B100152203; B100152204; B100152206; B100152207; B100152208; B100152209; B100152210; B100152211; B100152212; B100152213; B100152214; B100152215; B100152216; B100152217; B100152219; B100152220; B100152221; B100152222; B100152223; B100152224; B100152225; B100152226; B100152227; B100152229; B100152230; B100152231; B100152232; B100152233; B100152234; B100152236; B100152240; B100152240; B100152242; B100152243; B100152244; B100152245; B100152246; B100152247; B100152248; B100152249; B100152251; B100152273; B100152274; B100152275; B100152276; B100152277; B100152278; B100152279; B100152281; B100152282; B100152283; B100152284; B100152285; B100152286; B100152291; B100152294; B100152300; B100152303; B100152304; B100153101; B100153102; B100153201; B100153202; B100153203; B100153204; B100153205; B100153206; B100153207; B100153208; B100153209; B100153210; B100153211; B100153212; B100153213; B100153214; B100153215; B100153216; B100153217; B100153218; B100153219; B100153220; B100153221; B100153222; B100153223; B100153224; B100153225; B100153226; B100153227; B100153228; B100153229; B100153230; B100153231; B100153232; B100153233; B100153234; B100153235; B100153237; B100153238; B100153239; B100153240; B100153241; B100153243; B100153244; B100153260; B100153270; B100153276; B100153277; B100153279; B100153280; B100153283; B100153284; B100153285; B100153286; B100153287; B100153288; B100153289; B100153290; B100153291; B100153292; B100153293; B100153294; B100153295; B100153296; B100153297; B100153298; B100153299; B100153300; B100153301; B100155101; B100155102; B100155104; B100155201; B100155202; B100155203; B100155204; B100155205; B100155207; B100155208; B100155209; B100155210; B100155211; B100155212; B100155213; B100155214; B100155215; B100155216; B100155217; B100155219; B100155220; B100155221; B100155222; B100155223; B100155224; B100155225; B100155226; B100155227; B100155228; B100155229; B100155230; B100155231; B100155232; B100155233; B100155234; B100155235; B100155236; B100155237; B100155238; B100155239; B100155240; B100155241; B100155242; B100155243; B100155244; B100155245; B100155246; B100155247; B100155248; B100155249; B100155250; B100155251; B100155252; B100155253; B100155254; B100155255; B100155256; B100155257; B100155258; B100155259; B100155260; B100155261; B100155262; B100155263; B100155274; B100155275; B100155276; B100155277; B100155278; B100155279; B100155878; B100155880; B100155881; B100155882; B100155883; B100155884; B100155885; B100155886; B100155889; B100155892; B100155895; B100155897; B100155898; B100159101; B100159103; B100159105; B100159105; B100159201; B100159202; B100159203; B100159204; B100159205; B100159206; B100159207; B100159208; B100159209; B100159210; B100159211; B100159212; B100159213; B100159216; B100159217; B100159218; B100159219; B100159220; B100159221; B100159222; B100159239; B100159240; B100159241; B100159242; B100159243; B100159244; B100159245; B100159246; B100159247; B100159248; B100159250; B100159251; B100159252; B100159253; B100159254; B100159255; B100159256; B100159257; B100159258; B100159259; B100159260; B100159261; B100159262; B100159263; B100159264; B100159265; B100159266; B100159269; B100159270; B100159273; B100159274; B100159275; B100159276; B100159277; B100159278; B100159279; B100159280; B100159281; B100159282; B100159283; B100159284; B100159285; B100187101; B100187102; B100187201; B100187202; B100187203; B100187205; B100187206; B100187207; B100187207; B100187208; B100187209; B100187210; B100187211; B100187212; B100187213; B100187214; B100187215; B100187216; B100187218; B100187227; B100187228; B100187229; B100187230; B100187231; B100187232; B100187233; B100187234; B100187235; B100187236; B100187237; B100187238; B100187239; B100187240; B100187241; B100187243; B100187244; B100187245; B100187246; B100187249; B100187250; B100187251; B100187252; B100187253; B100187254; B100187255; B100187256; B100187257; B100187258; B100187259; B100187260; B100187261; B100187262; B100187263; B100187264; B100187265; B100187266; B100187267; B100187268; B100187269; B100187270; B100187271; B100188201; B100188202; B100188203; B100188204; B100188205; B100188206; B100188207; B100188208; B100188209; B100188210; B100188211; B100188212; B100188215; B100188216; B100188217; B100188218; B100188220; B100188221; B100188222; B100188223; B100188224; B100188225; B100188228; B100188229; B100188230; B100188231; B100188232; B100188233; B100188234; B100188235; B100188236; B100188237; B100188238; B100188239; B100188246; B100189201; B100189202; B100189203; B100189204; B100189205; B100189206; B100189208; B100189209; B100189210; B100189211; B100189212; B100189213; B100189214; B100189215; B100189216; B100189217; B100189218; B100189219; B100189220; B100189221; B100189222; B100189223; B100189224; B100189225; B100189226; B100189227; B100189228; B100189229; B100189230; B100189231; B100189232; B100189233; B100189235; B100189236; B100189237; B100189238; B100189238; B100189239; B100189241; B100189242; B100189243; B100189244; B100189245; B100189246; B100189247; B100189251; B100189252; B100189253; B100189254; B100189255; B100189256; B100189257; B100189258; B100189259; B100189260; B100189261; B100189262; B100189263; B100189264; B100189265; B100189266; B100189267; B100189268; B100189269; B100189270; B100189271; B100189272; B100189273; B100189274; B100189275; B100189276; B100189277; B100189278; B100189279; B100189280; B100189281; B100189282; B100189284; B110002101; B110002205; B110002206; B110002207; B110002208; B110002209; B110002210; B110002211; B110002212; B110002213; B110002214; B110002215; B110002216; B110002217; B110002218; B110002219; B110002220; B110002221; B110002222; B110002223; B110002224; B110002225; B110002226; B110002227; B110002228; B110002229; B110002230; B110002231; B110002232; B110002233; B110002234; B110002235; B110002236; B110002237; B110002238; B110002239; B110002240; B110002245; B110002246; B110002247; B110002248; B110002249; B110002250; B110002252; B110002255; B110002256; B110002257; B110002258; B110002259; B110002260; B110002261; B110002262; B110002263; B110002274; B110002275; B110002276; B110002278; B110002279; B110002280; B110002286; B110002287; B110002292; B110002293; B110002294; B110002295; B110002296; B110002297; B110002298; B110002299; B110002300; B110024202; B110024203; B110024204; B110024205; B110024206; B110024207; B110024208; B110024209; B110024210; B110024211; B110024212; B110024213; B110024214; B110024215; B110024216; B110024217; B110024218; B110024219; B110024220; B110024221; B110024269; B110024270; B110024271; B110024272; B110024273; B110024274; B110024275; B110024276; B110024277; B110024278; B110024279; B110024280; B110024281; B110024282; B110024283; B110024284; B110024285; B110024286; B110024287; B110024288; B110024289; B110024290; B110024291; B110024292; B110024294; B110024295; B110024296; B110024297; B110024298; B110024299; B110024300; B110024301; B110024302; B110024303; B110024304; B110024305; B110024306; B110024307; B110024307; B110024309; B110024310; B110024311; B110024312; B110024313; B110024314; B110024315; B110024316; B110024317; B110024318; B110024319; B110024320; B110024321; B110024322; B110024323; B110024324; B110024325; B110024326; B110024327; B110024328; B110024329; B110024330; B110024331; B110024332; B110024333; B110024334; B110024335; B110024336; B110024337; B110024338; B110024339; B110024340; B110024341; B110024342; B110024343; B110024344; B110024345; B110024346; B110024347; B110024348; B110024349; B110024350; B110024351; B110024352; B110024353; B110024354; B110024361; B110024363; B110025201; B110025202; B110025204; B110025213; B110025214; B110025215; B110025220; B110025221; B110025222; B110025223; B110025224; B110025225; B110025226; B110025227; B110025228; B110025261; B110025262; B110025264; B110025265; B110025266; B110025267; B110025268; B110025270; B110025273; B110025274; B110025275; B110025276; B110025277; B110025278; B110025279; B110025280; B110025281; B110025282; B110034101; B110034102; B110034201; B110034205; B110034206; B110034207; B110034208; B110034209; B110034210; B110034211; B110034212; B110034213; B110034214; B110034215; B110034216; B110034217; B110034218; B110034222; B110034223; B110034224; B110034225; B110034226; B110034227; B110034228; B110034229; B110034230; B110034231; B110034232; B110034233; B110034234; B110034235; B110034236; B110034237; B110034239; B110034240; B110034241; B110034242; B110034243; B110034244; B110034245; B110034247; B110034248; B110034250; B110034251; B110034252; B110034253; B110034254; B110034257; B110034258; B110034259; B110034260; B110034261; B110034262; B110034263; B110034264; B110034272; B110034273; B110034274; B110034275; B110034309; B110034315; B110034316; B110034319; B110034320; B110034321; B110034322; B110034323; B110034324; B110034327; B110034328; B110034329; B110034501; B110034502; B110034503; B110034504; B110034505; B110034506; B110034507; B110034508; B110034509; B110034510; B110034511; B110034512; B110034513; B110034514; B110034515; B110034516; B110034517; B110034518; B110037201; B110037202; B110037203; B110037204; B110037205; B110037206; B110037207; B110037210; B110037213; B110037214; B110037215; B110037216; B110037217; B110037218; B110037220; B110037220; B110037221; B110037222; B110037223; B110037224; B110037225; B110037226; B110037227; B110037228; B110037229; B110037230; B110037231; B110037232; B110037233; B110037234; B110037235; B110037244; B110037245; B110037247; B110037248; B110037249; B110037250; B110037251; B110037252; B110037253; B110037254; B110037255; B110037256; B110037257; B110037258; B110037264; B110037267; B110037268; B110037269; B110037270; B110037271; B110037272; B110037273; B110043201; B110043202; B110043203; B110043205; B110043206; B110043207; B110043208; B110043209; B110043210; B110043211; B110043212; B110043213; B110043214; B110043215; B110043216; B110043217; B110043218; B110043219; B110043220; B110043221; B110043222; B110043223; B110043224; B110043225; B110043226; B110043227; B110043228; B110043229; B110043230; B110043231; B110043232; B110043233; B110043234; B110043235; B110043236; B110043237; B110043239; B110043240; B110043241; B110043242; B110046221; B110046222; B110046223; B110046224; B110046225; B110046226; B110046228; B110046229; B110046236; B110046245; B110046246; B110046247; B110046248; B110046249; B110046250; B110046263; B110046264; B110046265; B110046266; B110046267; B110046268; B110046269; B110048101; B110048102; B110048202; B110048203; B110048204; B110048205; B110048206; B110048207; B110048208; B110048209; B110048210; B110048211; B110048212; B110048213; B110048214; B110048215; B110048216; B110048217; B110048218; B110048219; B110048220; B110048221; B110048222; B110048223; B110048224; B110048225; B110048226; B110048227; B110048228; B110048229; B110048230; B110048231; B110048232; B110048233; B110048234; B110048235; B110048236; B110048237; B110048238; B110048239; B110048240; B110048241; B110048242; B110048243; B110048244; B110048245; B110048246; B110048247; B110048248; B110048249; B110048250; B110048251; B110048252; B110048253; B110048254; B110048255; B110048256; B110048257; B110048258; B110048259; B110048260; B110048261; B110048262; B110048263; B110048264; B110048276; B110048277; B110048278; B110048279; B110048280; B110049202; B110049203; B110049204; B110049205; B110049206; B110049207; B110049208; B110049209; B110049210; B110049213; B110049214; B110049215; B110049216; B110049217; B110049218; B110049219; B110049220; B110049221; B110049222; B110049223; B110049224; B110049225; B110049226; B110049227; B110049228; B110049229; B110049230; B110049231; B110049232; B110049233; B110049234; B110049235; B110049236; B110049237; B110049238; B110049239; B110049240; B110049241; B110049242; B110049243; B110049244; B110049245; B110049246; B110049247; B110049248; B110049249; B110049250; B110049251; B110049252; B110049253; B110049254; B110049255; B110049256; B110049257; B110049258; B110049259; B110049260; B110049261; B110049262; B110049263; B110049264; B110049265; B110049266; B110049267; B110049268; B110049269; B110049270; B110049271; B110049272; B110049273; B110049274; B110049275; B110049276; B110049277; B110049278; B110049281; B110049282; B110049283; B110049284; B110049285; B110057201; B110057202; B110057203; B110057204; B110057205; B110057206; B110057207; B110057208; B110057209; B110057210; B110057211; B110057212; B110057214; B110057216; B110057218; B110057219; B110057221; B110057222; B110057223; B110057229; B110057240; B110057241; B110057243; B110057244; B110057245; B110057246; B110065214; B110065215; B110065216; B110065217; B110065218; B110065219; B110065220; B110065221; B110065222; B110065223; B110065224; B110065225; B110065226; B110065227; B110065228; B110065229; B110065232; B110065233; B110065234; B110065235; B110065236; B110065237; B110065238; B110068201; B110068204; B110068205; B110068206; B110068207; B110068208; B110068209; B110068210; B110068211; B110068212; B110068213; B110068214; B110068215; B110068220; B110068221; B110068222; B110068223; B110068233; B110082221; B110082222; B110082223; B110082224; B110082226; B110082227; B110082228; B110082231; B110082232; B110082233; B110082234; B110082256; B110082258; B110082259; B110082260; B110082263; B110082264; B110082265; B110082701; B110082702; B110082703; B110082705; B110082706; B110082707; B110082708; B110082709; B110082710; B110082711; B110082712; B110082713; B110082714; B110082715; B110082716; B110082717; B110082718; B110082719; B110082720; B110082721; B110082722; B110082725; B110082726; B110082727; B110082728; B110082729; B110082730; B110082731; B110082732; B110082733; B110082734; B110082735; B110082736; B110082737; B110082738; B110082739; B110082740; B110082741; B110082742; B110082743; B110082744; B110082745; B110082746; B110082747; B110082748; B110082749; B110082750; B110082751; B110082752; B110082753; B110082754; B110082755; B110082756; B110082757; B110082758; B110082759; B110082760; B110082761; B110082762; B110082763; B110082765; B110082766; B110082767; B110082768; B110082769; B110082770; B110082771; B110082772; B110082773; B110082774; B110082775; B110082776; B110082777; B110082778; B110082779; B110082780; B110082781; B110082782; B110082783; B110082784; B110082785; B110082786; B110082787; B110082788; B110082790; B110082791; B110082792; B110082793; B110082794; B110082795; B110082796; B110082797; B110082798; B110082799; B110082801; B110082802; B110082803; B110082804; B110082805; B110082806; B110082807; B110082808; B110082809; B110082810; B110082811; B110082813; B110082814; B110082815; B110082816; B110082817; B110082818; B110082819; B110082820; B110082821; B110082822; B110082824; B110082825; B110082826; B110082827; B110082828; B110082829; B110082830; B110082831; B110082832; B110082833; B110082834; B110082835; B110082836; B110082838; B110082839; B110082840; B110082841; B110082842; B110082843; B110082844; B110082845; B110082846; B110082847; B110082848; B110082850; B110082851; B110082852; B110082853; B110082854; B110082855; B110082856; B110082857; B110082858; B110082860; B110082861; B110082862; B110082863; B110082864; B110091201; B110091202; B110091203; B110091204; B110091205; B110091206; B110091207; B110091208; B110091209; B110091210; B110091211; B110091212; B110091214; B110091215; B110091216; B110091217; B110091218; B110091221; and B110091222 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Bacterin International Inc. Biologics Division
Biologics Fascia product is derived from donated cadaver human tissue. It was prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label. B100124252 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Bacterin International Inc. Biologics Division
Biologics Red Blood Cells Leukocytes Reduced Irradiated W051511076332; W051511074167; W051511075950; Class II Blood products, collected from donors whose arm preparation was inadequate, were distributed. Memorial Blood Centers
Biologics Red Blood Cells W051511074195; W051511074261; W051511074258; W051511056112; W051511074282; W051511074204; W051511073797; W051511073804; W051511074012; W051511074015; W051511075942; W051511074095; W051511074092; W051511074097; W051511072056;W051511074260; W051511056105; W051511056113; W051511074135; W051511074008; W051511074009; W051511075962; W051511072123; W051511074061; W051511074105; W051511074189; W051511075952; W051511074265; W051511074369; W051511072007; W051511072021; W051511074399; W051511074395; W051511072067; W051511056107; W051511056115; W051511073818; W051511072019; W051511056116; Class II Blood products, collected from donors whose arm preparation was inadequate, were distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W051511076343; W051511074068; W051511074381; W051511072051; W051511074376; W051511074081; W051511074213; W051511074276; W051511073834; W051511072128; W051511076395; W051511072059; W051511073815; W051511072046; W051511074363; W051511056114; W051511074268; W051511076338; W051511074216; W051511074161; W051511074207; W051511075940; W051511075960; W051511072113; W051511072117; W051511072132; Class II Blood products, collected from donors whose arm preparation was inadequate, were distributed. Memorial Blood Centers
Biologics Fresh Frozen Plasma W051511076332; W051511076343; W051511074068; W051511074167; W051511074195; W051511074261; W051511074258; W051511074381; W051511072051; W051511074200; W051511074143; W051511072067; W051511074061; W051511072113; W051511072117 Class II Blood products, collected from donors whose arm preparation was inadequate, were distributed. Memorial Blood Centers
Devices Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Spinbrush Pro Clean Soft (6687800078) Spinbrush Pro Clean Medium (6687800079) Spinbrush Pro Clean Replacement Head Soft 2 ct (6687800080) Spinbrush Pro Clean Replacement Head Medium 2 ct (6687800081) Spinbrush Pro Clean 3 ct BJs (6687800145) Spinbrush Pro Clean 2 ct (6687800425) Spinbrush Pro Clean Extra Soft 2 ct (6687800433) Spinbrush Pro Clean Combo Pack (6687800461) Spinbrush Pro Clean Value Pack (6687800466) Spinbrush Pro Clean Soft Value Pack (6687800709) Total Spinbrush Pro Clean Spinbrush Pro Recharge Spinbrush Pro Clean Recharge (6687800160) Total Spinbrush Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Spinbrush Pro Clean Recharge (6687800160) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Spinbrush Pro Whitening Soft (6687800191) Spinbrush Pro Whitening Replacement Head Soft 2 ct (6687800192) Spinbrush Pro Whitening Medium (6687800193) Spinbrush Pro Whitening Replacement Head Medium 2 ct (6687800194) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush (668780016201) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush (668780016202) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush (668780016400) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal Arm and Hammer Spinbrush Pro White Sonic Toothbrush (668780016401) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS (6687800614408) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094001) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Devices Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094002) Class II Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. Church & Dwight Inc
Biologics Red Blood Cells Leukocytes Reduced 8440344; 8440289, 8440288, 8440281, 8432734, 8433109, 8433451, 8427671, 8438591, 8439520, 8436503, 8436512, 8436506, 8436605, 8436606, 8441668, 8433614, 8433616, 8438156, 8438147, 8438146, 8447972, 1001530, 1001841, 1002531, 8445631, 8447551, 8447474, 8447473, 8447409, 8447489, 8447490, 8447408, 8447492, 8447493, 8443193, 8441733, 8441739, 8441742, 8441687, 8441689, 8441738, 8443186, 8443192, 8443196, 8443006, 8443005, 8444010, 8443934, 8444007, 8443804, W09101131135000, W09101131130900, W09101130659700, W09101130598000, W09101130287900 , W09101129552300, W09101129577700, W09101131203400, W09101129593200, W09101129583100, W09101130232000, W09101130683100, W09101129895900, W09101130595600, W09101129878300, W09101128740300, W09101130594900, W05171164398100, W09101131675500, W09101131578100, W03681130545500, W05171164933000, W05171164936700, W05171164930500, W05171164929600, W05171164718300, W03951145404300, W33361110232000, W33361111000100, W33361110139500, W04441131117000, W12161119376500, W05331150655100, W05331160910800, W03951145293600, W33361110429800, W33361110859000, W33361109602200, W03951145294200, W04441150670800, W04441150670400, W04441170583800, W33361110456700, W33361108461700, W33361109603000, W05331160951600, 8438848, 8432450, 8420822, 8420824, 8429327, 8442021, 8442020, 8423761, 8423759, 8423763, 8423760, 8423762, 8431103, 8431096, 8431147, 8431218, 8431221, 8431222, 8431220, 8431148, 8431149, 8431150, 8431153, 8431235, 8431224, 8431234, 8431057, 8431059, 8431060, 8431064, 8421618, 8421620, 8421616, 8421627, 8421623, 8421624, 8421533, 8424309, 8424244, 8421284, 8421285, 8421287, 8421286, 8421281, 8421181, 8421194, 8421187, 8421191, 8421179, 8421177, 8432986, 8432987, 8433037, 8433044, 8436103, 8435014, 8435015, 8435036, 8435037, 8435090, 8435099, 8435111, 8435115, 8435116, 8435118, 8435121, 8435122, 8437717, 8440015, 8440014, 8440307, 8440301, 8440453, 8433900, 8433889, 8433892, 8433895, 8427545, 8427462, 8427442, 8427645, 8427653, 8427512, 8427659, 8425050, 8425052, 8425057, 8425113, 8425262, 8425265, 8425267, 8425268, 8435924, 8435883, 8435890, 8435994, 8435998, 8435716, 8435722, 8435724, 8435727, 8445271, 8445279, 8441364, 8441360, 8441363, 8441300, 8441295, 8441294, 8441348, 8441296, 8441302, 8441303, 8442535, 8442520, W09101127389500, W09101127481000, W09101124990900, W09101125892800, W09101128043500, W09101126938100, W09101126938800, W09101125807400, W09101127417300, W09101128162600, W09101127819400, W09101128163400, W09101129088800, W09101129300600, W09101128720100, W09101128732200, W09101127330200, W09101129000900, W09101129293900, W09101129294000, W09101128720000, W09101129323100, W09101131080900, W09101130235500, W09101131066400, W09101129502800, W09101131815000, W09101131277400, W09101130852000, W09101131833000, W06711107805300, W09101130526300, W09101131277800, W09101130826900, W09101131825800, W09101130827200, W09101127181100, W09101131826000, W09101131277100, W09101131278200, W09101132112000, W09101130220100, W09101130853700, W09101131335800, W09101130813100, W09101130225700, W09101131065900, W03681127693900, W11651131411000, W11651131412100, W11651131412300, W11651131411100, W11651131411700, W03681120059100, W03681129744700, W03681129744400, W03681120059400, W03681123915400, W03681129312500, W08791180564900, W08791180564300, W08791180563000, W03681126586500, W03681126156400, W03681126421300, W03681121095700, W03681126520700, W03681120434400, W03681126521000, W03681126586300, W03681121777500, W03681126421600, W03681120459400, W03681120355100, W03681128209200, W05171163809500, W05171163591600, W05171163520500, W05171163591300, W03681126451000, W03681130348800, W03681130621000, W33361104422300, W33361109098800, W33361108715200, W03951144758000, W33361108092400, W03951144628800, W33361107957900, W33351101762100, W33341101685800, W33361108643700, W33361108090200, W03951144755900, W33361109342600, W33361108427700, W33361108617400, W33341101272200, W33341101482100, W33341101294100, W33341101294600, W03951143392100, W33361106066700, W33351101707200, W33361108171300, W33351101681100, W33361108245500, W33361108245300, W33361108076200, W33361108238700, W33361108246200, W33361108242700, W33361109055400, W04441130916000, W04441170477200, W04441130924400, W33341101670900, W04441130924300, W33341101671200, W03951144784300, W33361106068800, W04441130925400, W33351101754600, W33351101753300, W33361107891200, W33341101609100, W33341101541100, W12161117622500, W12161117448700, W12161117813100, W12161117783400, W12161117813000, W12161117448500, W03951144773300, W33341101802000, W03951144876400, W33341101801500, W33341101804200 W33351101783100, W03951144392000, W33341101582300, W33341101805900, W33361104348800, W12161119166700, W12161119436600, W12161119610500, W33361109896800, W33361109013700, W33341101929800, W33361108879900, W33361109637200, W33361109211000, W33361109636300, W33361109896100, W33361108453600, W33361110583200, W33341101782100, W03951144924600, W33361110585900, W33361108573200, W33361108972200, W05171164107900, 8447984, 8447836, W09101131661400, W09101131636100 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Fresh Frozen Plasma 7906862, 7906870, 7906873, 7906877, W12361100144900, W12361100145000, W12361100145300, W12361100147100, W12361100147300, W12361100147400, W03681111542700, W03681107539000, W03681110925000, W03681118531800, W03681112027400, W03681108575700, W03681117991400, W03681111325400, W03681118504400, W03681110945200, W03681121552600, W03681122143200, W05171164413600, W05171164413900, W05171164581000, W05171111394800, W05171164580800, W05171164318100, W05171111357900, W05171111377300, W05171164575800, W05171164603400, W05171164512800, W05171164601700, W05171164601100, W05171164600600, W05171140880400, W12361100160500, W12361100160900, W05171163937600, W05171163799700, W05171163884700, W05171163249100, W05171163274400, W05171130266100, W05171164667600, W05171164952500, W05171164514100, W05171164048100, W05171164741400, W05171120359700, W05171140939700, W05171164289200, W05171140826300, W05171164039300, W05171164135100, W05171120310100, W05171111283200, W05171111297500, W05171140825600, W05171165053000, W05171111505900, W05171164813700, W05171164813000, W05171164484800, W03681120656800, W05171164579700, W05171111384500, W05171164348100, W05171164441500, W05171140892200, W05171140891800, W05171164611200, W05171164392100, W05171164513600, W05171164348600, W05171164144600, W05171164267300, W05171164267200, W05171120337100, W05171150373300, W05171140894200, W05171164579300, W05171164578900, W05171111369000, W05171164606100, W05171164604300, W05171163811900, W05171130265200, W05171163787200, W05171163785000, W05171120290200, W05171111205000, W05171164887400, W05171164891200, W05171164199000, W05171164718000, W05171165140900, W05171165200100, W05171165178200, W05171165175600, W03681120704900, 8417138, 8417139, W05171164506300, W05171164505300, W05171164460600, W05171164862200, W05171165050100, W05171164192900, W05171164347300, W05171120330400, W05171164413700, W05171140892800, W05171111179700, W05171164737600, W05171164762200, W05171111555200, W05171111572300, W05171164833900, W05171164324600, W05171165100900, W05171164448700, W05171165100300, W05171111523900, W05171111520200, W05171164149900, W05171130347700 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Cryoprecipitated AHF, Pooled 1002682, 1002686, 1002685, 1002683, 1002684, 1002779, 1002681 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Platelet Pheresis Leukocytes Reduced Irradiated 8446741, 1001150, 8446743, 1002276, 1002251, 1000624, 1000686, 8435643, 8433585, 8444533, 8427355, 8436046, 8433649, 8436045, W12781120286000, E05211100678200 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Red Blood Cells 8433046, 8433045, W12161118809800, 8430533, 8430390, 8433300, 8433297, 8433293, 8433287, 8430389, W12161119002500, 8437455, w12161118809500, W12161118802500, W12161119033100, W12161119032600, W12161119079000, 8437456, 8437453, 8433203 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Platelet Pheresis Leukocytes Reduced W14091211078600, W33361108852000, W14091121651300, 8438920, 8434095, W09101128748600, W14091121642200, W14091121651200, W33361110978000, 8438441, W09101133902400, W14091211599300, W03581200781800, W03581201730100, W14091210304200, W14091210303800, W14091210304800, W09101130646900, W14091121697300, W03581201183600, 8438912, 8438913, 8438922, W14091210309200, W14091210310600, 1002980, W05171111702400, 8440672, W14091211155400, 8440671, W14091211155400, W14091121632000, W03951144709800, W09101127756000, W03581121729100, W09101130004100, W33361108521800, W03581118618100, W03581119806600, W05211100662800, W09101129852600, W09101132237500, W09101128899100, W14091211576600, W03581118702500, W03581117037100, W03581119692900, 8434094, W03581200452900, 8431833, W03581120054400, W09101127744000, 8441151, W03681130391200, W14091211087300 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics FP24 W33341101954700, W33341101800000, W33361110410700, W33361110162500, W33361111100500, W33341101913400, W33361110265700, W03951145189400, W33361110888800, W33361109223100, W33361111172900, W03951145063500, W03951145186900, W09101130724500, W09101128795900, W03951145185900, W33361110023300, W33361111152200, W03951144823600, W09101131130400, W09101130087800, W09101126841300, W09101129502800, W33341101955600 , W09101130683600, 8426192 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Red Blood Cells Apheresis Leukocytes Reduced 8430878, 8430799, 8431565, 8425625, 8425623, 8423797, 8430709, 8436539, 8436264, 8436272, 8436302, 8436231, 8436305, 8436268, 8436544, 8433964, 8434015, 8434016, 8434025, 8434029, 8434030, 8434031, 8434032, 8434285, 8434286, 8434348, 8438626, 8439095, 8439089, 8439093, 8435740, 8435828, 8435824, 8434461, 8434466, 8434468, 8434472, 8439096, 8439097, 8439101, 8439108, 8439105, 8439103, 8439104, 8440948, 8440950, 8440949, 8441037, 8440956, 8440954, 8441042, 8441038, 8441039, 8441044, 8441045, 8441046, 8442214, 8442203, 8442263, 8444433, 8447363, 8443574, 8430671, 8430684, 8430678, 8430683, 8431544, 8431562, 8430666, 8430670, 8428182, 8428184, 8428503, 8428488, 8428487, 8428139, 8428138, 8426096, 8430708, 8430428, 8430713, 8430711, 8430716, 8436256, 8436257, 8436777, 8436737, 8436772, 8433914, 8433962, 8434022, 8434024, 8434026, 8434027, 8434028, 8434033, 8434390, 8434391, 8434392, 8434396, 8434402, 8434428, 8434429, 8438517, 8438524, 8438519, 8438521, 8438530, 8438522, 8438523, 8438512, 8435308, 8435548, 8435551, 8435375, 8435382, 8435289, 8435739, 8435819, 8435823, 8434307, 8434308, 8434311, 8434312, 8434397, 8434400, 8434403, 8434405, 8434414, 8434418, 8440460, 8440462, 8440465, 8442262, 8442265, 8442955, 8442966, 8444436, 8447436, 8447438, 8447439 , W33361108147900 (bag 1 &2); W03681120133000, W03681120133000, W04441130925100, 8438847, W05171111291100 (bag1 &2) ;W05171165030600 (bag1 &2); 8434270; 8438305, ;8438248, 8438249, 8440962, ;8440968, 8440963, 8440964, 8440976, 8436886, 8436394, 8436522, 8436523, 8436390, 8436532, 8436535, 8448584, 8448395, 1001785, 1001805, 1002677, 8445977, 8445974, 8446139, 8446130, 8446131, 8440938, 8440930, 8435918, 8438214, 8438215, 8438217, 8438206, 8438212, 8438216, 8438220, 8438219, 8438732, 8440886, 8438017, 8436885, 8436898, 8439994, 8439999, 8448581, 8449474, 8445975, 8446123, W04441250025000, W04441111183500, W03681126258500, W03681235662800, W33361111227100, 1002678, 1002680, 1002676, 1002679, 8446129, 8448679, 8448681 Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Fresh Frozen Plasma Apheresis W03681121290100; W03681119762600; W03681127687000; W03681123988500; W03681121840900; W05171130338500; W05171150390400; W03681127433100; W03681110651300; W05171111485500; W03681110652300; W03681127323100; W05171111498100; W03681127331200; W03681131889800; W03681123908700; W03681121776800; W03681120590300; W03681122054000; W05171130308300; W05171111574100 (bag 1 and bag 2) Class III Unlicensed blood products were distributed in interstate commerce. Metro Blood Services
Biologics Human semen for intracervical insemination and/or intrauterine insemination. Vials are labeled with the donor number, date of donation, and "Seattle Sperm Bank". Vials that are for intrauterine insemination (IUI-ready) have a green color band indicating it is ready for intra uterine insemination after thawing. Vials that do not have a green band indicate that the semen is an intra cervical insemination sample (ICI). Vials are labeled with the donor number. Affected donor numbers are: 8503, 8505, 8508, 8509, 8521, 8523, 8528, 8534, 8535, 8543, 8547, 8552, 8558, 8566, 8578, 8579, 8582, 8598, 8609, 8612, 8615, 8625, 8636, 8643, 8652, and 8664 Class II Human semen, collected from donors that did not have repeat physical exam within 6 months prior to donation, was distributed. Seattle Sperm Bank LLC
Drugs Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13 Class I A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified. Eagle Pharmaceuticals Inc.
Biologics Haemonetics MCS+9000 Pump Encoder Automated Blood Cell Separator Model LN 9000 Serial Numbers: 00A124-1 00F002-1 00F003 00F046-1 00F047-1 01M260 01M264 01 M265-1 01M279-2 01M282-2 02B151-2 02B155-2 02B156-2 02B157-2 02B160-3 02C033-3 02C036-3 02C037-3 02M202-1 02M203-1 03E020 03E021 03E075 03E076 03F089 04J033 04K025 04K026 04M080 04M081 04M082 05C014 05D056 05F064-1 05G101 05G103 05K067-1 06A297 06B355 06B357-1 06C075-1 06C076-1 06C361-1 06C362-1 06C363-1 06G004 06G005 06G006 06G008 06L117 06L118 06L119 07E194 07E195 07E269 07E270 07E271 07E274-1 07H336 07H340 07J101 07J102 07J103 07J179 07J180 07J190 07J192 07J297 08A325 08A326 08A327 08A328 08A345 08A348 08J142 08J143 08J144 08J408 08J409 08J410 08J411 08J412 08J498 08K030 08K031 08K033 08K034 09B093 09B294 09B295 09B296 09B297 09B298 09B299 09B300 09B301 09B302 09C056 09C057 09C058 09C059 09C060 09C167 09C168 09C169 94A124-MC+9 94A 127 -MC+9 94A 129-MC+9 94A130-1 94A135U-1 94A 138-MC+9 94A 139-MC+9 94A 146U-MC+ 94A147-MC+9 94A 149U-MC+ 94A151 U-MC+ 94A 152U-MC+ 94A 154-MC+9 94F275-MC+9 94F276-MC+9 94F290-MC+9 94F291-MC+9 95M039-MC+9 95M040-MC+9 95M041-MC+9 95M042-MC+9 95M043-MC+9 95M044-MC+9 95M081-MC+9 95M082-MC+9 95M083-MC+9 95M085-MC+9 95M086-MC+9 95M170U-MC-t 95M173U 95M174-MC+9 95M175-MC+9 95M177-MC+9 95M182U-1 95M191-MC+9 95M192-MC+9 95M194-MC+9 95M196U 95M198-MC+9 95M200-MC+9 96A044U-MC+ 96A045-MC+9 96A220-MC+9 96A221-MC+9 96A222-MC+9 96A223U-MC+ 96A225U-MC+ 96A226-MC+9 96B042-MC+9 96B043 96B044 96B046-MC+9 96B047-MC+9 96C078-MC+9 96C079-MC+9 96C195 96C370-MC+9 96C372-MC+9 96C373-MC+9 96C374U-MC+ 96C375-MC+9 96C376-MC+9 96C378-MC+9 96C380-MC+9 96C381-MC+9 96C478-MC+9 96C479-MC+9 96C484-MC+9 96C485 96D003-MC+9 96D004-MC+9 960008U 960099-MC+9 960101-MC+9 960102-MC+9 96D103-MC+9 96D104-MC+9 96D105-MC+9 96E041-MC+9 96E042-MC+9 96E042U 96E043-MC+9 96E044-MC+9 96E044U 96E045-MC+9 96E046-MC+9 96E047-MC+9 96E048-MC+9 96E049-MC+9 96E050-MC+9 96E051-MC+9 96E052-MC+9 96E053-MC+9 96E054-MC+9 96E207-MC+9 96E208-MC+9 96E209-MC+9 96E210-MC+9 96E323-MC+9 96E324U-MC+ 96F056-MC+9 96F059 96F068 96F092-MC+9 96F093-MC+9 96F095U-MC+ 96F097 96F097 -MC+9 96F097U 96F098-MC+9 96F105-MC+9 96F270-MC+9 96F271-MC+9 96F272-MC+9 96F273-MC+P 96F276-MC+9 96F278-MC+9 96F279-MC+9 96F280-MC+9 96F281-MC+9 96F283-MC+9 96F414-MC+9 96F415-MC+9 96F416-MC+9 96F418-MC+9 96F420-MC+9 96F422-MC+9 96F424-MC+9 96F425-MC+9 96F579-MC+9 96F580-MC+9 96F583-MC+9 96F584-MC+9 96F585-MC+9 96F586-MC+9 96F587 -MC+9 96F588-MC+9 96G103-MC+9 96G104-MC+9 96G106-MC+9 96G107-MC+9 96G108-MC+9 96K073-MC+9 96K074-MC+9 96K076-MC+9 96K077 -MC+9 96K078-MC+9 96K170-MC+9 96K171-MC+ 96K175C-1 96K176C-1 96K182U-MC+ 96K184-MC+9 96K185-MC+9 96K186U 96K188U 96L252-MC+9 96L339-MC+9 96L340-MC+9 96L341-MC+9 96L343-MC+9 96L426-MC+9 96L430U 96L432-MC+9 96L433 96M041-MC+9 96M042-MC+9 96M046-MC+9 96M047-MC+9 96M048-MC+9 96M049-MC+9 96M421-MC+9 96M425-MC+9 96M427 -MC+9 96M428-MC+9 96M429-MC+9 96M436-MC+9 96M437 -MC+9 96M438-MC+9 97B037 -MC+9 97B038-MC+9 97B040-MC+9 97B041-MC+9 97B042-MC+9 97B043-MC+9 97B204-MC+9 97B206-MC+9 97B320-MC+9 97B326-MC+9 97B326U-2 97B327 -MC+9 97B384-MC+9 97B386-MC+9 97B388-MC+9 97B389-MC+9 97B391-MC+9 97B392-MC+9 97D108-MC+9 97D109-MC+9 97D109U-2 97D112U-1 97D114U-MC+ 97D408-MC+9 97EOO1-MC+ 97E001U 97E006-MC+9 97E008-MC+9 97E009-MC+9 97E494-MC+9 97E499-MC+9 97E500-MC+9 97E501-MC+9 97F099-MC+9 97F174-MC+9 97F175-MC+9 97F177 -MC+9 97F178-MC+9 97F179-MC+9 97F265-MC+9 97F266-MC+9 97F267 -MC+9 97F268-MC+9 97F271 U-1 97F272-MC+9 97F273-MC+9 97F275-MC+9 97J130-MC+9 97J131-MC+9 97 J 132-MC+9 97 J 134-MC+9 97 J 135-MC+9 97 J 136-MC+9 97 J 185-MC+9 97 J 186-MC+9 97J191-MC+9 97 J192-MC+9 97 J222-MC+9 97 J223-MC+9 97 J224-MC+9 97 J225-MC+9 97J227-1 97 J228-MC+9 98C134-MC+9 98F128-MC+9 98F129-MC+9 98F136U 98H043 98H044-MC+9 98H046-MC+9 98H112-MC+9 98H113-MC+9 98H114-MC+9 98H115-MC+9 98H116-MC+9 98H117-MC+9 98H118 99L136 99L137 99L 139-MC+9 Class III Apheresis Collection Devices, with a possible pump encoder failure, were distributed. Haemonetics Corporation
Biologics Haemonetics Cymbal Automated Blood Collection Model LN1900 Serial Numbers: 07A180-1 07M111 06A252U-1 07B115-1 06A255 06K067-1 07B209-1 06K066-1 07B104-1 07B208-1 08K224 08K227 08K260 08K226 07B114-1 07B117-1 07B192-1 07A181-1 07A182-1 07B110-1 07B193-1 07M108 07M085 07M105 07M107 07M109 07M110-1 07M112 07M113 07B105U-1 07A172-1 07B109-1 06K075-1 07A178-1 07A183-1 07B200-1 07B206-1 07M341-1 07M342-1 07B211-1 07L040 07A175-1 07L183 06A261U-1 07A184-1 07B108-1 07B106-1 08K225 07M117 08K223 08K255 07M118 08K258 07M116 08K254 08K256 08K257 08K259 07M114 07B204-1 07A174-1 07B111-1 06K070-1 07L032 07C302-1 06K080-1 06K064-1 07M115 07B210-1 07M106-1 06K063-2 06K068-1 06K069-1 07B194-1 07B202-2 07B201-1 07B191-1 07B113-1 07B195-1 07B116-1 07B189-1 07A179-1 07B203-1 07B112-1 07B205-1 07B207-1 06K072-1 Class III Apheresis Collection Devices, with a possible pump encoder failure, were distributed. Haemonetics Corporation
Devices Smiths Medical, Medfusion® Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. 2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 2000258 2000259 2000260 2000261 2000262 2000263 2000264 2000265 2000266 2000267 2000268 2000269 2000270 2000271 2000272 2000273 2000274 2000275 2000276 2000277 2000278 2000279 2000280 2000281 2000282 2000283 2000284 2000285 2000286 2000287 2000288 2000289 2000290 2000291 2000292 2000293 2000294 2000295 2000296 2000297 2000298 2000299 2000300 2000301 2000302 2000303 2000304 2000305 2000307 2000308 2000309 2000310 2000311 2000312 2000313 2000314 2000315 2000316 2000317 2000318 2000319 2000320 2000321 2000322 2000323 2000324 2000325 2000326 2000327 2000328 2000329 2000330 2000331 2000332 2000333 2000334 2000336 2000337 2000338 2000339 2000340 2000341 2000342 2000343 2000344 2000345 2000346 2000347 2000348 2000349 2000350 2000351 2000352 2000353 2000354 2000355 2000356 2000357 2000358 2000359 2000360 2000361 2000362 2000363 2000364 2000365 2000366 2000367 2000368 2000369 2000370 2000371 2000372 2000373 2000374 2000375 2000376 2000377 2000378 2000379 2000380 2000381 2000382 2000383 2000384 2000385 2000386 2000387 2000388 2000389 2000390 2000391 2000392 2000393 2000394 2000395 2000396 2000397 2000398 2000399 2000400 2000401 2000402 2000403 2000404 2000405 2000406 2000408 2000409 2000412 2000413 2000414 2000415 2000416 2000417 2000418 2000419 2000422 2000423 2000425 2000426 2000428 2000430 2000431 2000433 2000434 2000436 2000437 2000438 2000439 2000440 2000441 2000442 2000443 2000445 2000446 2000447 2000448 2000449 2000450 2000451 2000452 2000453 2000454 2000455 2000456 2000457 2000458 2000459 2000460 2000461 2000462 2000463 2000464 2000465 2000466 2000467 2000468 2000469 2000470 2000471 2000472 2000473 2000474 2000475 2000476 2000477 2000478 2000479 2000480 2000481 2000482 2000483 2000484 2000485 2000486 2000487 2000488 2000489 2000490 2000491 2000492 2000493 2000494 2000495 2000496 2000497 2000498 2000499 2000500 2000501 2000502 2000503 2000504 2000505 2000506 2000507 2000508 2000509 2000510 2000511 2000512 2000513 2000514 2000515 2000516 2000517 2000518 2000519 2000520 2000521 2000522 2000523 2000524 2000525 2000526 2000527 2000528 2000529 2000530 2000531 2000532 2000533 2000534 2000535 2000536 2000537 2000538 2000539 2000540 2000541 2000542 2000543 2000544 2000545 2000546 2000547 2000548 2000549 2000550 2000551 2000552 2000553 2000554 2000555 2000556 2000557 2000558 2000559 2000560 2000561 2000562 2000563 2000564 2000565 2000566 2000567 2000568 2000569 2000570 2000571 2000572 2000573 2000574 2000575 2000576 2000577 2000578 2000579 2000580 2000581 2000582 2000583 2000584 2002080 2002081 2002082 2002083 2002084 2002085 2002086 2002087 2002089 2002090 2002091 2002092 2002093 2002094 2002095 2002096 2002097 2002098 2002099 2002100 2002101 2002102 2002103 2002104 2002105 2002106 2002107 2002108 2002109 2002110 2002111 2002112 2002113 2002114 2002115 2002116 2002117 2002118 2002119 2002120 2002121 2002122 2002123 2002124 2002125 2002128 2002129 2002130 2002131 2002132 2002133 2002134 2002135 2002136 2002137 2002138 2002139 2002140 2002141 2002142 2002143 2002144 2002145 2002146 2002147 2002148 2002149 2002150 2002151 2002152 2002153 2002154 2002155 2002156 2002157 2002158 2002159 2002160 2002161 2002162 2002163 2002164 2002165 2002166 2002167 2002168 2002169 2002170 2002171 2002173 2002174 2002175 2002176 2002177 2002178 2002179 2002180 2002181 2002182 2002183 2002184 2002185 2002186 2002187 2002188 2002189 2002190 2002204 2002205 2002206 2002207 2002208 2002209 2002210 2002211 2002212 2002213 2002214 2002215 2002217 2002218 2002219 2002220 2002221 2002222 2002223 2002224 2002225 2002226 2002227 2002228 2002229 2002230 2002231 2002232 2002233 2002234 2002235 2002236 2002237 2002238 2002239 2002240 2002242 2002244 2002245 2002246 2002247 2002248 2002249 2002250 2002251 2002252 2002254 2002256 2002257 2002258 2002259 2002260 2002261 2002262 2002263 2002264 2002265 2002267 2002268 2002269 2002270 2002271 2002273 2002274 2002275 2002276 2002277 2002278 2002279 2002280 2002281 2002282 2002284 2002285 2002286 2002287 2002288 2002289 2002290 2002291 2002292 2002293 2002294 2002295 2002296 2002297 2002298 2002299 2002300 2002301 2002302 2002303 2002304 2002306 2002308 2002309 2002310 2002311 2002312 2002313 2002314 2002315 2002316 2002317 2002318 2002319 2002320 2002321 2002322 2002323 2002325 2002326 2002327 2002328 2002329 2002330 2002331 2002332 2002333 2002334 2002335 2002336 2002337 2002338 2002340 2002341 2002342 2002343 2002345 2002346 2002348 2002349 2002350 2002351 2002352 2002353 2002354 2002357 2002358 2002359 2002360 2002371 2002372 2002373 2002374 2002375 2002376 2002377 2002563 2002564 2002565 2002566 2002567 2002568 2002569 2002570 2002571 2002572 2002573 2002574 2002575 2002576 2002577 2002578 2004514 2004528 2004531 2004536 2004537 2004538 2004541 2004542, and 2004550. Class I Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation. Smiths Medical ASD, Inc.
Biologics Cornea 20110475OS, 20110475OD Class II Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. International Sight Restoration, Inc.
Food Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Lot numbers SP1094A2, Exp 04/04/2013; SP1153B2, Exp 06/02/2013; SP1319C2, Exp 11/15/2013 and SP2013C2, Exp 01/13/2014 Class III The products contain undeclared soy lecithin Defense Nutrition
Food Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA. Lot number SP1332E2, Exp 12/28/2013 Class III The products contain undeclared soy lecithin Defense Nutrition
Food Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL. Lot numbers SP1355B2, Exp. 12/21/2013 and SP2067A2, Exp 3/7/2014 Class III The products contain undeclared soy lecithin Defense Nutrition
Veterinary Wardley Advanced Nutrition Perfect Protein Tropical Fish Flake Food Net Wt. 1 OZ. (28 g) UPC 0-43324-00591-7 Made in the USA by The Hartz Mountain Corporation Secaucus, New Jersey 07094 Lot PP34911, PP34912, PP35011, and PP35012 Class I Fish food may be contaminated with Salmonella Hartz Mountain Corp.
Devices Integra® Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint. Model #181041S, Batch #s EKU8, EN2D, EN2B, EMOK & EN2B; Model #181051S, Batch #s EJQY, FOSU, ECEB & E179; Model #181041, Batch #s EB1E, EBKY, ECE9, EHA7, E647, E8NP, E8P7, E8ML, E8N5, E8PV, E8N5 & E5GV; Model #181042, Batch #s E648, EB1F, E8MM, E8NQ, E8PW, E5GW, E8N6, E8P8, E5GY, E8PW & EBKZ; Model #181052, Batch #s E5GY, E64A, E8PY, E5GW, E8PA, E8NS, E8N8, E8MP & EB1H; Model #181051, Batch #s E649, E5GX, E8MN, E8N7, E8P9, E8NR, E8PX, ECEB, EJ79, EB1G, EBLO & ECEB; Model #181052S, Batch #s E8PY, EB1H, EB14 & E8MP; Model #181042S, Batch #s E8MM, EB1F & EBKZ. Class II Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. Integra LifeSciences Corp.
Veterinary Kaytee Forti-Diet Pro Health Mouse, Rat & Hamster, with DHA Omega-3 supports Heart, Brain & Visual Functions. Nutritionally Enhanced Daily Diet for a long, happier, healthier life. Packaged into the following sizes and UPC codes. - 3lb (1.36 kg), UPC 71859-99994, - 5lb. (2.27kg) UPC 71859-00001; - 25 lb. (11.34 kg) UPC 71859-99995; and - 25 lb bags for use within Petco stores UPC 71859-00000. Manufactured by: Kaytee Products, Inc., Chilton, WI 53014 USA. Best Before Codes: 30 Mar 2013 (25 lb - Petco stores only), 31 Mar 2013 (25 lb), 31 Mar 2013 K63 (6/3 lb), and 03 Apr 2013 K61 (6/5 lb) Class I Kaytee Pet Products is recalling a single manufacturing batch of Kaytee Forti-Diet Pro Health Mouse, Rat and Hamster due to possible contamination with Salmonella Central Garden & Pet Company
Devices Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119 Class II Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product. Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design. Zimmer Inc.
Devices Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update. Class II Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product. Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design. Zimmer Inc.
Biologics Red Blood Cells Leukocytes Reduced 033FQ44139; Class II Blood products, collected from a donor who was previously deferred, were distributed. Arc Blood Services, New England Region
Biologics Recovered Plasma 033FQ44139; Class II Blood products, collected from a donor who was previously deferred, were distributed. Arc Blood Services, New England Region
Biologics Platelets Pooled Leukocytes Reduced POOL#50506; Class II Blood products, collected from a donor who was previously deferred, were distributed. Arc Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated 033FY66023; 033FY66024; 033FY66025; 033FY66026; 033FY66027; 033FY66028; 033FY66029; 033FY66030; 033FY66031; 033FY66032; 033FY66033; 033FY66034; 033FY66035; 033FY66037; 033FY66038; 033FY66039; 033FY66040; 033FY66041; 033FY66013; 033FY66014; 033FY66015; 033FY66016; 033FY66017; 033FY66018; 033FY66019; 033FY66020; 033FY66021; 033FY66022; 033FY66047; 033FY66048; 033FY66049; 033FY66050; 033FY66051; 033FY66042; 033FY66043; 033FY66044; 033FY66045; 033FY66046; Class III Blood products, collected using equipment for which quality control was not performed, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 033FY66036; Class III Blood products, collected using equipment for which quality control was not performed, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Washed W115911274341; Class II Blood products, collected from a donor who traveled to a malaria endemic area, were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W115912081153; W115911048352; Class II Blood products, collected from a donor who traveled to a malaria endemic area, were distributed. Central California Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W115911014575; Class II Blood products, collected from a donor who traveled to a malaria endemic area, were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115912050151; W115911055120; W115911087792; W115911086284; W115911028245; W115911026948; W115911028133; W115911026079; W115911242742; W115911276347; W115911056484; W115911055417; W115911283967; W115911087172; W115911265921; W115911265619; W115911086370; W115911265213; W115911265258; W115911026455; W115911025188; W115911046827; W115911273078; W115911046723; W115911242945; W115911242946; W115911276348; W115911055415; W115911084863; W115911087547; W115912250344; W115911276278; W115912040618; W115911087738; W115912080071; W115911201854; W115911027557; Class II Blood products, collected from a donor who traveled to a malaria endemic area, were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W043211063102; W043210098418; W043210058610; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Recovered Plasma W043211063102; W043210098418; W043210058610; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Pooled W043210058610; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced W044112107244 Part 1; W044112107244 Part 2; Class II Blood products, which did not meet acceptable product specifications, were distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W044112109670; W044112107244 Part 3; Class II Blood products, which did not meet acceptable product specifications, were distributed. LifeServe Blood Center
Veterinary Wellness Complete Health Super5Mix Large Breed Puppy, packaged in: 15 lb. and 30 lb. bags and 5 oz. sample bags Product Code: 89591 UPC: 4 00 76344 89591 4 Super5Mix Large Breed Puppy 12/5oz;. Product Code: 89114 UPC: 0 76344 89114 7 Super5Mix Large Breed Puppy 15 lb.; Product Code: 89115 UPC: 0 76344 89115 4 Super5Mix Large Breed Puppy 30 lb. Best by dates of JAN 9 2013 through JAN 11 2013. Class I Product maybe potentially contaminated with salmonella (manufactured by Diamond Pet Foods) Wellpet Llc
Biologics Red Blood Cells Leukocytes Reduced W044611295391; Class II Blood products, collected from a donor who was previously deferred, were distributed. Gulf Coast Regional Blood Center
Biologics Plasma Frozen After 24 Hours W044611295391; Class II Blood products, collected from a donor who was previously deferred, were distributed. Gulf Coast Regional Blood Center
Biologics Capture-R Ready Indicator Red Cells Lot/Serial Number 221812 Class III Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed. Immucor Inc
Biologics Source Plasma 0630042647; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Drugs Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1. Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14 Class III Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found. Mallinckrodt Inc.
Drugs Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1. Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13 Class II CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. Mallinckrodt Inc.
Biologics SoftBank II versions 23.1 and 25.1 applications are decision support software devices. SoftBank II versions 23.1 documents the receipt of inventory from an outside source, multi-side inventory control, records the confirmatory testing on the units and allows for records keeping on component preparation for transfusion. Soft Bank II versions 23.1 and 25.1 Class II Software, with a glitch or defect, was distributed. SCC Soft Computer
Biologics Source Plasma 2160062308; 2160068966; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081036; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160063498; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059814; 2160067375; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058180; 2160062907; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160073430; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160062987; 2160074078; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063042; 2160063876; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160078137; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064991; 2160069116; 2160070885; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058966; 2160059586; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082085; 2160070284; 2160069890; 2160073365; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160079822; 2160080589; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063733; 2160065091; 2160066720; 2160068524; 2160069915; 2160083083; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069116; 2160070885; 2160064991; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063963; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066587; 2160071412; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081922; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Devices I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood. List number 03P76-25 Lot number S10246A Class II i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer. Abbott Point Of Care Inc.
Food Oyster IQF L size Frozen Wild, 10/4lbs. JFC#03751 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Food PAFCO Oyster Meat Tiny IQF, 40/8 oz. JFC#21757 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Food Oyster M Frozen Farm, 10/4 lbs. JFC#47341 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Food Breaded Oyster Frozen, 10/2 lbs. JFC#63669 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Food Tablemark Kaki (Oyster) Fry, 2/12/6.34 oz. JFC#17208 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Food Pacific Surf Breaded Oyster Fry, 12/2 lbs. JFC#03479 Class II JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. J F C International Inc
Drugs Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880. Lot #s: 412572A, 412572B, Exp 11/12 Class III Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. Watson Laboratories Inc
Drugs Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, 50 unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 Lot #'s 210900, 214000, 220100, 224800, 228700, 232800 Class II Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume. VistaPharm, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W1151121841133; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112166816A; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112156534P; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036512047744; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W041612006849W; W041612006809B; W041611056969L; W041611057366M; Class II Blood products, collected using equipment that had not been validated, were distributed. Blood Systems Inc/dba United Blood Services
Devices OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. 62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030 Class II Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached. GE OEC Medical Systems, Inc
Devices OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging. 62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030 Class II Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached. GE OEC Medical Systems, Inc
Devices UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion. 62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030 Class II Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached. GE OEC Medical Systems, Inc
Food Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi The drink can is stamped on the underside with the code: IHMAY0913XXXX; [XXXX = military time of the day; IH = ITO EN HAWAII; MAY0913 = Expiry code presenting product was produced on May 9, 2012 and will expire on May 9, 2013] Class III Product has off-smell and off-taste and should not be consumed. Itoen (USA) Inc
Devices Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions. Receiver Product number 109207. Class II Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm. Sunrise Medical (US) LLC
Food Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include: Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk. Also made with cow's milk: Pianoforte, Nocturne. Goat's milk cheese varieties: Acapella, Impromptu, Pastoral, Fresh Goat and Crottin, Minuet, a triple-creme goat's milk variety. Mixed Milk cheese varieties: Rondo, Metronome, Melange. Other varieties include Cavatina, Contralto, Vivace, Partita, Tri, Mini Alto, Figaro,Cadence No code information Class II Lack of proper pasteurization could have allowed dangerous pathogens to survive in multiple lots of cheese. Andante Dairy
Biologics Sunquest Laboratory Blood Bank and Blood Donor Sunquest Blood Bank and Blood Donor versions: Sunquest Blood Bank and Blood Donor versions 6.0.1 Distributed with Sunquest Laboratory 6.1; 6.0.1 Distributed with Sunquest Laboratory 6.2; 6.0.2 Distributed with Sunquest Laboratory 6.3; 6.4 Distributed with Sunquest Laboratory 6.4 Class III Software, with a glitch or defect, was distributed. Sunquest Information Systems, Inc.
Devices RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications. REF 0406-630-115, lot 1000035056 Class II Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn. Stryker Instruments Div. of Stryker Corporation
Devices RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications. REF 0406-630-125, lot 1000037535 Class II Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn. Stryker Instruments Div. of Stryker Corporation
Devices Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument. Serial Numbers: 20210001 through 20210078 Class II Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT Perkinelmer
Devices Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A020, A021, A022, A023, A024, AO25, A026 Class II Digital Skin Mammography Marker separating from the backing of the spot material Beekley Corporation
Devices Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A015, A016, AO17, A018 Class II Digital Skin Mammography Marker separating from the backing of the spot material Beekley Corporation
Devices Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046 Class II Digital Skin Mammography Marker separating from the backing of the spot material Beekley Corporation
Devices Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain Lot Numbers: A004 Class II Digital Skin Mammography Marker separating from the backing of the spot material Beekley Corporation
Devices Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment. all lots and serial numbers Class II Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette. Baxter Healthcare Renal Div
Devices High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568 Class II The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. ICU Medical, Inc.
Devices Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment. Part Number 460730418 510(k) K052865 Lot number 2444750 Class II The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. ICU Medical, Inc.
Devices 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing Part Number B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687. Class II The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. ICU Medical, Inc.
Devices Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit Part Number AG8137 510(k) K052865 Lot number 2466161 Class II The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. ICU Medical, Inc.
Devices INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 420256-01 Lot numbers: D120745, D120755, D120835, D120865. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Intuitive Surgical, Inc.
Devices IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only. Iris Diagnostics part number 800-0074, lot number 131-12. Class III The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive. Iris Diagnostics
Food Winn-Dixie Cheeseburger Macaroni Skillet Dinner WD Code 202410, Size 5.8 oz WD Code 202410, Lot# 051413CA85, Sell by date 05/14/2013 Class II Potentially contains small metal fragments Winn Dixie Stores, Inc.
Devices Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty Sizes: 1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151 4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151 Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Devices Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty. Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151 Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Devices Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Sizes: 4.5x18mm Catalog # 320-20-18 Serial Range 1610445-2381151 4.5x22mm Catalog # 320-20-22 Serial Range 1610391-2381151 4.5x26mm Catalog # 320-20-26 Serial Range 1611237-2381151 4.5x30mm Catalog # 320-20-30 Serial Range 1617556-2381151 4.5x34mm Catalog # 320-20-34 Serial Range 1611290-2381151 4.5x38mm Catalog # 320-20-38 Serial Range 1610260-2381151 4.5x42mm Catalog # 320-20-42 Serial Range 1630006-2381151 4.5x46mm Catalog # 320-20-46 Serial Range 1644317-2381151 Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Devices Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Catalog Number 324-11-00 Serial Range 1653706-2381151 Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Devices Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Catalog Number 324-15-05 Serial Range 1620549-2381151 Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Devices Octane-C Cervical, 6º Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7). Sizes: 5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers Class II Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. Exactech, Inc.
Drugs Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9 Lot #s: JN1060, JN1061, JN1062, Exp 06/12 Class II Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. Apotex Inc.
Devices Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment. Model # 1180.16F2 Serial #s 1,3,7, & 8; Model # 1180.16F3 Serial # 1; Model #1180.16F5 Serial #4; Model # T285.7000 Serial #s 1,2,3,4, & 7. Class II As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive. Maquet Medical Systems, Usa
Drugs Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05 C201293 Exp Date 08/2013 Class II Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets. Dr. Reddy's Laboratories, Inc.
Drugs Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05 C201293 Exp Date 08/2013 Class II Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets Dr. Reddy's Laboratories, Inc.
Drugs Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10. Lot #: ML9605 Exp. 10/2013 Class II Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet. Zydus Pharmaceuticals USA Inc
Food WE-24541 Vit/Min Premix Toddler (1-4 yr old) w/o DHA*ARA, NET WEIGHT 22.68 KG LOT NUMBER: 61104094 Class I The product contains Galactooliosaccharide which was recalled due to possible salmonella contamination. The Wright Group dba Wright Enrichment, Inc.
Food Spillson's Texas BBQ Beef Sandwich, 4 oz. Best By July 20, 2012 - August 3, 2012 Class I Undeclared soy and wheat found in the flour ingredient of the Texas BBQ Beef sandwich. People with an allergy or sensitivity to soy or wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Bologna & Cheese Sandwich, Nt. Wt. 4 oz Best By July 20-August 3, 2012 Class II Undeclared wheat found in the flour ingredient, undeclared soy lecithin in cheese product. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. The Big Sicilian Sandwich Nt. Wt. 7oz Best By July 20-August 3, 2012 Class II Undeclared yellow # 5 found in the sandwich pepper ingredient. People with a sensitivity to yellow # 5 run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Ham Sandwich Nt. Wt. 7 oz Best By July 20-August 3, 2012 Class II Undeclared wheat found in the sandwich flour ingredient and undeclared soy lecithin in the cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Meatball Sub Sandwich Nt. Wt. 10 oz Best By July 20-August 3, 2012 Class II Undeclared wheat found in the sandwich flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd.Greek Pita Sandwich Nt. Wt. 7oz. Best By July 20-August 3, 2012 Class II Undeclared wheat found in the sandwich flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Smoked Turkey & Swiss Pita Sandwich, 7 oz. Best By July 20-August 3, 2012 Class II Undeclared wheat found in the sandwich flour ingredient. Undeclared soy lecithin in the Cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Ham & Swiss Pita Sandwich, 7 oz. Best By July 20-August 3, 2012 Class II Undeclared wheat. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Ham & Turkey Combo Sandwich, 9 oz. Best By July 20-August 3, 2012 Class II Undeclared wheat and soy not declared as source of the lecithin ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Sausage & Egg Muffin Sandwich, 6oz. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Club Sub Sandwich, 7oz. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat in flour ingredient . People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Roast Beef Sandwich 97% Fat Free, 7oz. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in the cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Super Italian Sandwich , 10 oz. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat in flour ingredient, undeclared yellow #5 in the pepper ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Pizza Boat, 4 oz. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat in flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Cheeseburger Sandwich. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Double Cheeseburger Sandwich. Best By July 20-August 3, 2012 Class II Sandwich contains undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Food Spillson's Ltd. Breakfast Muffin Sandwich, 6 oz Ham Best By July 20-August 3, 2012 Class II Sandwich contains undeclared wheat found in the flour ingredient and undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product. Spillson's, Ltd.
Devices Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient 4 degree - SJ768T-US and 9 degree SJ780T-US Class II The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree trial instrument (SJ768T-US). The incorrect etching was not identified at final inspection. Aesculap Implant Systems LLC
Drugs Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25). Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13 Class II Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. West-ward Pharmaceutical Corp.
Drugs Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10). Lot #s: a) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 102325.1, Exp 11/12; 102342.1, 102343.1, 102344.1, 102345.1, Exp 12/12; 112019.1, 112020.1, 112021.1, 112022.1, 112023.1, Exp 01/13; 112156.1, 112157.1, 112158.1, 112159.1, 112160.1, Exp 05/13; 112164.1, Exp 06/13; 112203.1, 112204.1, 112205.1, 112206.1, Exp 07/13; 112262.1, 112263.1, Exp 09/13; 112301.1, 112302.1, 112303.1, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13 Class II Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. West-ward Pharmaceutical Corp.
Drugs Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30, Lot D12044, Exp 4/2014, NDC 0904-5255-30 Class III Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014 Axcentria Pharmaceuticals LLC
Drugs OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7. Lot #: V006015, V006023, V006031, V006056, V006064, V006080, V006106, V006114, V006130, V006148, V006155, Exp 07/12; V006171, V006189, V006197, V006205, V006213, V006221, V006254, V006262, V006270, V006296, V006304, V006312, V006320, V006338, V006346, V006353, V006361, V006379, V006387, V006395, Exp 08/12; V006403, V006429, V006437, V006445, V006460, V006494, V006510, V006528, V006536, V006544, Exp 09/12. Class II Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter. Cadence Pharmaceuticals
Drugs Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin. Lot Number: 81202450, Exp 06/15/16 Class II Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. Bayer HealthCare Pharmaceuticals Inc.
Food Crispy Just Baked Punjabi Cookies sold in 800 gr clamshell packages. Manufactured by : TWI Foods, Inc., Mississauga, ON, Canada. UPC 6 27265 00152 0 Class I FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Foods, Canada that may not declare milk as an ingredient. CHETAK SAN FRANCISCO LLC.
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