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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64206
Product Type Biologics
Status Terminated
Recalling Firm Florida Lions Eye Bank, Inc.
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 0801006COS, 0801006COD, 0801016COD, 0801016COS, 0801020COD, 0801022COS, 0801022COD, 0802009COSG2, 0802009COD, 0802009COSG1, 0802015COD, 0802015COSGPC, 0802015COS, 0802023COD, 0802023COS, 0802060COS, 0802060COD, 0802076COD, 0802076COS, 0802080CODG2, 0802080CODG1, 0802080COSG1, 0802080COSG2, 0802084COSG1, 0802084COSG2, 0802084CODG1, 0802084CODG2, 0803007COS, 0803007COD, 0803011COD, 0803011COS, 0803025COS, 0803025COD, 0803025COSGPC, 0803058COD, 0803076CODG1, 0803076CODG2, 0803076COSG2, 0803076COSG1, 0804015COD, 0804015COS, 0804042COD, 0805019COSG2, 0805019COSG1, 0805019COD, 0805056COS, 0805056COD, 0805056COSGPC, 0805064COD, 0805064COS, 0806007COD, 0806007COS, 0806014CODG2, 0806014COS, 0806014CODG1, 0806018COD, 0806018COS, 0806022COS, 0806022COD, 0806024COD, 0806024COSG2, 0806024COSG1, 0806032CODGPC, 0806032COSG1, 0806032COD, 0806032COSG2, 0806040CODG1, 0806040CODG2, 0806040COSG2, 0806040COSG1, 0806046COSG2, 0806046COSG1, 0806046CODG2, 0806046CODG1, 0806058COS, 0806058COD, 0807006COS, 0807006COD, 0807037COS, 0807037COD, 0807041COS, 0807041COD, 0807049COD, 0807049COS, 0808009COD, 0808009COS, 0808009COSGPC, 0808009CODGPC, 0808012COD, 0808041COD, 0808041COS, 0808046COS, 0808046COD, 0808046COSGPC, 0808046CODGPC, 0809002COD, 0809002COS, 0809028COD, 0809028COS, 0809075COSGPC, 0809075COS, 0809075COD, 0810002COD, 0810002COS, 0810012CODG2, 0810012COS, 0810012CODG1, 0810041COS, 0810041COD, 0811008CODG1, 0811008CODG2, 0811008COSG2, 0811008COSG1, 0811057COS, 0811057CODGPC, 0811057COD, 0811069COD, 0811069COS, 0811080CODG1, 0811080COSG1, 0811080CODG2, 0811080COSG2, 0811084COSG1, 0811084CODG2, 0811084CODG1, 0811084COSG2, 0812015COD, 0812015COS, 0812045CODG2, 0812045CODG1, 0812045COSG2, 0812045COSG1, 0812045COD, 0812059COSG2, 0812059COSG1, 0812059CODG2, 0812059CODG1, 0812060COD, 0812060COS, 0901001COS, 0901001COD, 0901016COD, 0901016COS, 0901021COS, 0901021COD, 0901055COS, 0901055COD, 0901059COS, 0901059COD, 0901066CODGPC, 0901066COS, 0901066COD, 0902020COS, 0902020COD, 0902028COD, 0902028COS, 0902032COS, 0902032COD, 0902043CODG1, 0902043CODG2, 0902043COSG1, 0902043COSG2, 0902061COSG1, 0902061COSG2, 0902061COD, 0903004WEOS, 0903004CODG1, 0903004SOD2, 0903004SOD3, 0903004SOD5, 0903004CODG2, 0903004SOD1, 0903004SOD4, 0903004SOD6, 0903004SOD7, 0903004SOD8, 0903027COD, 0903050COSG1, 0903050COD, 0903050COSG2, 0904012COS, 0904012COD, 0904039COSG1, 0904039COD, 0904039COSG2, 0904041COD, 0904041COS, 0904047COS, 0904047COD, 0904065COD, 0904065COS, 0904095COSG2, 0905006COSG1, 0905006COD, 0905006COSG2, 0905012COS, 0905012COD, 0905067COSG2, 0905067CODG1, 0905067CODG2, 0905067SOSW, 0905067SODW, 0905067COSG1, 0906011COS, 0906011COD, 0907015CODG1, 0907015COS, 0907015CODG2, 0907016SOD1, 0907016SOD2, 0907016SOD3, 0907016SOD4, 0907016CODG1, 0907016SOD7, 0907016SOD8, 0907016SOS1, 0907016SOS3, 0907016SOS4, 0907016COSG2, 0907016SOS7, 0907016COSG1, 0907016SOD5, 0907016SOD6, 0907016SOS2, 0907016SOS5, 0907016SOS6, 0907016CODG2, 0907025COSG1, 0907025COSG2, 0907025SOSW, 0907025SODW, 0907025CODG1, 0907025CODG2, 0907045COS, 0907045COD, 0908048COS, 0908048CODG2, 0908048CODG1, 0909009COD, 0909009COS, 0909022WEOD, 0909059CODG1, 0909059CODG2, 0909059COSG1, 0909059COSG2, 0909059SOSW, 0909059SODW, 0909073COS, 0909073COD, 0909078COSG2PC, 0909078COSG1PC, 0909078CODG1PC, 0909078CODG2PC, 0909089COD, 0909089COS, 0910002COS, 0910003COSG1, 0910003SOSW, 0910003SODW, 0910003COSG2, 0910003CODG1, 0910003CODG2, 0911007COS, 0911007COSGPC, 0911007COD, 0911008COD, 0911008CODGPC, 0911008COS, 0911021COS, 0911021COD, 0911033COSGPC, 0911033COD, 0911033COS, 0911040CODG2, 0911040COSG2, 0911040COSG1, 0911040CODG1, 0911065COD, 0911065COS, 0912002CODG2, 0912002SOS2, 0912002SOS7, 0912002SODW, 0912002SOS1, 0912002SOS3, 0912002SOS4, 0912002SOS5, 0912002SOS6, 0912002SOS8, 0912002COSG1, 0912002COSG2, 0912002CODG1, 0912013COS, 0912013COD, 0912022COS, 0912022COD, 0912052CODG1, 0912052CODG2, 0912062COS, 0912062COD, 1001004COD, 1001004COS, 1001008SOSW, 1001008CODG1, 1001008SODW, 1001008CODG2, 1001008COSG1, 1001008COSG2, 1001009COD, 1001009COS, 1001010COD, 1001010COS, 1001011CODG2, 1001011CODG1, 1001011COSG1, 1001011COSG2, 1001016COSG1, 1001016COSG2, 1001016WEOD, 1001016SOSW, 1001017COD, 1001017CODGPC, 1001017COSGPC, 1001017COS, 1001052COD, 1001052COS, 1001090COD, 1001096COS, 1001096COD, 1002008SOD2, 1002008SOS4, 1002008SOD1, 1002008SOD8, 1002008SOD7, 1002008SOS6, 1002008CODG2, 1002008COSG2, 1002008SOD3, 1002008SOD4, 1002008SOD5, 1002008SOD6, 1002008SOS1, 1002008SOS2, 1002008SOS7, 1002008SOS8, 1002008CODG1, 1002008COSG1, 1002008SOS3, 1002008SOS5, 1002009COD, 1002009COS, 1002009CODGPC, 1002009COSGPC, 1002035COS, 1002035COD, 1002066COD, 1002066COS, 1003002COD, 1003002COS, 1003010COD, 1003010COS, 1003016COS, 1003016COD, 1004031COD, 1004031COS, 1004037COS, 1004037COD, 1004045CODG2, 1004045COSG1, 1004045CODG1, 1004045COSG2, 1004049COS, 1004049CODG1, 1004049CODG2, 1004050COD, 1004050COS, 1004051CODG2, 1004051CODG1, 1004051COSG1, 1004051SODW, 1004051SOSW, 1004051COSG2, 1004054COD, 1004054COS, 1004054COD, 1004054COS, 1004077COS, 1004077CODG2, 1004077CODG1, 1004079COD, 1004079COS, 1005004COSG1, 1005004COD, 1005004COSG2, 1005009COD, 1005009COSG1, 1005009COSG2, 1005011COD, 1005011COS, 1005013CODG2, 1005013CODG1, 1005013COSG2, 1005019COS, 1005019COD, 1005021COD, 1005021COS, 1005023CODG2, 1005023COS, 1005023CODG1, 1005024COD, 1005024COS, 1005037COD, 1005037COSG1PC, 1005037COSG2PC, 1005037COSGPC, 1005060CODG1, 1005060CODG2, 1005060COS, 1005063COSGW, 1005067COD, 1005067COS, 1005077COD, 1005077COS, 1005078COD, 1005078COS, 1005079COS, 1005079COD, 1006002COD, 1006002COS, 1006005COS, 1006005COD, 1006013COD, 1006013COS, 1006014COSG1, 1006014CODG1, 1006014CODG2, 1006014COSG2, 1006021COD, 1006021COS, 1006027COD, 1006027COS, 1006033COD, 1006033COS, 1006049COD, 1006049COS, 1006053COS, 1006053COD, 1006055COD, 1006055COS, 1006059COD, 1006059COS, 1006067CODG1, 1006067COS, 1006067CODG2, 1007001CODG2, 1007001CODG1, 1007001COS, 1007007COD, 1007007COS, 1007008COS, 1007008COD, 1007010COD, 1007010COS, 1007014COD, 1007014COS, 1007019COS, 1007019COD, 1007024COD, 1007024COS, 1007041COS, 1007041COD, 1007043COD, 1007043COS, 1007052COSG1, 1007052COSG2, 1007052CODG1, 1007052SODW, 1007052SOSW, 1007052CODG2, 1007055COD, 1007055COS, 1007062COS, 1007062CODG1, 1007062CODG2, 1007064CODG1, 1007064COSG1, 1007064SODW, 1007064SOSW, 1007064CODG2, 1007064COSG2, 1007072COD, 1007072COS, 1008004CODG1PC, 1008004CODG2PC, 1008004CODGPC, 1008004COS, 1008005COD, 1008005COS, 1008008COS, 1008008COD, 1008009COD, 1008009COS, 1008019COS, 1008019COD, 1008022COD, 1008022COS, 1008036COD, 1008036COS, 1008042CODG1, 1008042COSG1, 1008042COSG2, 1008042CODG2, 1008077COD, 1008077COSG1PC, 1008077COSG2PC, 1008079COD, 1008079COS, 1009001CODG1, 1009001CODG2, 1009001COSG1, 1009001COSG2, 1009046COS, 1009046COD, 1009057SODW, 1009057COSG2, 1009057SOSW, 1009057CODG1, 1009057CODG2, 1009057COSG1, 1009061COS, 1009061COD, 1010006CODG1, 1010006CODG2, 1010006COSG1, 1010006COSG2, 1010012COS, 1010012COD, 1010035SOS1, 1010035SOS2, 1010035SOS3, 1010035COSG2, 1010035COD, 1010035SOD1, 1010035SOD2, 1010035SOD4, 1010035SOS4, 1010035SOD3, 1010037COS, 1010037SODW, 1010037SOSW, 1010037COD, 1010044CODG1, 1010044CODG2, 1010044COS, 1010044SOD1, 1010044SOD2, 1010044SOD3, 1010044SOD4, 1010044SOS1, 1010044SOS2, 1010044SOS3, 1010044SOS4, 1010051COD, 1010051COS, 1010066COD, 1010066COS, 1011006SOS6, 1011006COS, 1011006SOS5, 1011006SOD5, 1011006SOD6, 1011006SOD8, 1011006SOS3, 1011006SOS4, 1011006SOS7, 1011006SOS8, 1011006SOD3, 1011006SOD1, 1011006SOD2, 1011006SOD4, 1011006SOS1, 1011006SOS2, 1011006COD, 1011028CODG2, 1011028COSG1, 1011028COSG2, 1011028SOS2, 1011028SOS3, 1011028SOS1, 1011028CODG1, 1011028SODW, 1011034COSG1, 1011034CODG2, 1011034CODG1, 1011034COSG2, 1011040COD, 1011040SOD1, 1011040SOD2, 1011040COS, 1011045COD, 1011045COS, 1012021CODG2, 1012021CODG1, 1012044COD, 1012044COS, 1101042CODG1, 1101042CODG2, 1101042COSG1, 1101042COSG2, 1101061COD, 1101061COS, 1101064COS, 1101064COD, 1101070CODG1PCBED, 1101070CODG2PCBED, 1101070COS, 1101074CODG1, 1101074CODG2, 1101074COS, 1101084CODG1, 1101084CODG2, 1101084COSG1, 1101084COSG2, 1102007COD, 1102007COS, 1102030COD, 1102030COS, 110232CODG1PCBED, 110232CODG2PCBED, 102032COSG1PCBED, 1102032COSG2PCBED, 1102033COD, 1102033COSG1, 1102033COSG2, 1102044COD, 1102044COSG1, 1102044COSG2, 1103024COD, 1103024COS, 1103028COD, 1103028COSG1, 1103028COSG2, 1103057COD, 1103057COS, 1103063COD, 1103063COS, 1105017COD, 1105017COSG1, 1105017COSG2, 1105026COD, 1105026COS, 1105039COD, 1105039COS, 1105053COD, 1105053COS, 1106002CODG1, 1106002CODG2, 1106002COSG1, 1106002COSG2, 1106056COSGW, 1107036COD, 1107036COS, 1107045CODG1, 1107045CODG2, 1107045COS, 1107047COS, 1108027CODG2PCBED, 1108027CODG1PCBED, 1108027CODG2PCBED, 1108027COS, 1108027CODG1PCBED, 1108027CODGPCCAP, 1108031COD, 1108031COS, 1108045CODG1, 1108045CODG2, 1108045COSG1, 1108045COSG2, 1108050COD, 1108050COSG1, 1108050COSG2, 1108075COD, 1108075COS, 1108076CODG2, 1108076CODG1, 1108076COSG1, 1108076COSG2, 1108079COD, 1108079COS, 1202048SOSW, 1202048COS, 1202048SODW, 1202048COD Class III Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. 693 B-0971-13
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