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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-2309-13
Classification Class II
Code Info JK0443489; JK0449951; JK0450409; JK0451626; JK0451960; JK0459403; JK0459850; JK0460471; JK0460935; JK0461584; JK0462093; JK0464244; JK0464515; JK0417096;
Product Distributed Qty 14
Reason For Recall Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed

Event Detail

Event Id 65598
Product Type Biologics
Status Terminated
Recalling Firm DCI Biologicals, LLC
City Jacksonville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern United Kingdom