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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 65599
Product Type Biologics
Status Terminated
Recalling Firm University Of Miami Miller School of Medicine Tissue Bank
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-23
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Mississippi; Puerto Rico; Maryland; Florida; Guatemala; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bone 0111510146; 0111510147; 0111510148; 0111510131; 0111510132; 0111510133; 0111510134; 0111510135; 0111510136; 0111510137; 0111510138; 0111510139; 0111510140; 0111510066; 0111510068; 0111510070; 0111510071; 0111510072; 0111510073; 0111510074; 0111510075; 0111510076; 0111510077; 0111510078; 0111510079; 0111510080; 0111510081; 0111510082; 0111510083; 0111510091; 0111510096; 0111510097; 0111510098; 0111510099; 0111510100; 0111510101; 0111510102; 0111510103; 0111510104; 0111510105; 0111510106; 0111510107; 0111510108; 0111510109; 0111510110; 0111510111; 0111510112; 0111510113; 0111510114; 0111510115; 0111510121; 0111510123; 0111510150; 0111510152; 0111510153; 0111510154; 0111510119; 0111510149; 0112840072; 0112840073; 0112840074; 0112840075; 0112840076; 0112840077; 0112840078; 0112840080; 0112840081; 0112840086; 0112840082; 0112840085; Class II Human tissue allografts, associated with positive culture results, were distributed. 70 bone allografts B-2183-13
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