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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63238
Product Type Biologics
Status Terminated
Recalling Firm DCI Donor Services Tissue Services Division
City Nashville
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-31
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern New Mexico; California

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Skin 030539712; 030539982; 030539984; 030511381; 030511382; 030511388; 030511390; 030512003; 030513334; 030513335; 030513336; 030515326; 030515327; 030515777; 030517764; 030517766; 030517769; 030517777; 030518353; 030521200; 030521201; 030521206; 030521207; 030522051; 030522052; 030522056; 030524991; 030524994; 030525179; 030525253; 030529885; 030530134; 030532171; 030520430; 030521191; 030521194; 030533264; 030533266; 030534536; 030534875; 030539711 Class II Skin allografts, lacking assurance of proper temperature maintenance during transportation, were distributed. 41 B-0053-13
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