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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 63909
Product Type Biologics
Status Completed
Recalling Firm Pacific Coast Tissue Bank
City Los Angeles
State CA
Country US
Voluntary/Mandated FDA Mandated
Recall Initiation Date 2012-11-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern nationwide and world wide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Item 27f Batch Numbers: 09104, 09106, 09114, 09115, 10115, 11103, 11117 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 4,146 units B-1546-13
Item 27g Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10115, 11103, 11117, 11118, 12102 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 6,896 units B-1547-13
Item 70a Batch Numbers: 09105, 09107, 09108, 09109, 09111, 09112, 09121, 10101, 10102, 10104, 10107, 10110, 10111, 10112, 10113, 10114, 10117, 10118 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 13,069 units B-1548-13
Item 70 Batch Numbers: 09102, 09105, 09107, 09108, 09110, 09112, 09113, 09118, 10101, 10103, 10104, 10105, 10106, 10107, 10108, 10110, 10112, 10113, 10114, 10116, 10117 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 10,630 units B-1549-13
Item 71 Batch Numbers: 09102, 09105, 09107, 09108, 09109, 09110, 09111, 09112, 09113, 09118, 09121, 10101, 10113 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 2,038 units B-1550-13
Item 80a Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 3,126 units B-1551-13
Item 83cx Batch Numbers: 09109, 09110, 09111 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 264 units B-1552-13
Item 80a Batch Numbers: 091116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 194 allografts B-1553-13
Item 27f Batch Numbers: 09116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 814 allografts B-1554-13
Item 27g Batch Numbers: 09116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 152 allografts B-1555-13
Item 70 Batch Numbers: 09119, 19120 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. 1,594 allografts B-1556-13
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