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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584
Recall Number B-1669-13
Classification Class III
Code Info FM13A15027
Product Distributed Qty 16,740 units
Reason For Recall BLOOD-PACK Units in which the platelet container is incorrectly labeled as "AS-1 Red Blood Cell Adenine-Saline added", were distributed.

Event Detail

Event Id 65044
Product Type Biologics
Status Ongoing
Recalling Firm Fenwal Inc
City Lake Zurich
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-24
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US (CA, OR, OH, MI)