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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Blood Pack Unit with an Integrally Attached Container of ADSOL Red Cell Preservation Solution. NDC# 0942-6453-03
Recall Number B-0076-14
Classification Class III
Code Info FM13E09013
Product Distributed Qty 1 unit
Reason For Recall Mislabeled Blood-Pack Units were distributed.

Event Detail

Event Id 66240
Product Type Biologics
Status Ongoing
Recalling Firm Fenwal Inc
City Lake Zurich
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Canada
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