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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Fresh Frozen Plasma (Apheresis)
Recall Number B-1095-12
Classification Class III
Code Info W04121100687200R,W04121100687200R, W04121100687200R, W04121100687200R, W041211006911008, W041211006911008, W04121100694100X, W04121100694100X, W04121100694100X, W04121100694100X, W04121100696700D, W04121100696700D, W04121102271100O, W04121102271100O, W04121102271100O, W04121102271100O, W04121102400900*, W04121102400900*, W04121102400900*, W04121102400900*, W04121102419600Z, W04121102419600Z, W04121102419600Z, W04121102419600Z, W04121103027400Y, W04121103027400Y, W04121103027400Y, W04121103027400Y
Product Distributed Qty 28 units
Reason For Recall Blood product, manufactured with lactated ringer's solution instead os normal saline, was distributed.

Event Detail

Event Id 60013
Product Type Biologics
Status Terminated
Recalling Firm Blood Systems, Inc.
City Albuquerque
State NM
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-06
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern NM