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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Event Detail

Event ID 67925
Product Type Devices
Status Completed
Recalling Firm Terumo Cardiovascular Systems Corp
City Ashland
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern CA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 Lot Number: RA-27 Class II Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo® Cardiovascular Procedure Kits 37 units Z-1465-2014