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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-2443-13
Classification Class II
Code Info W280313700618 Part 1 ; W280313700618 Part 2;
Product Distributed Qty 2
Reason For Recall Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.

Event Detail

Event Id 65858
Product Type Biologics
Status Terminated
Recalling Firm Upstate New York Transplant Services
City Buffalo
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-03
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern New York
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