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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64383
Product Type Devices
Status Ongoing
Recalling Firm Salyer Prn Biomedical
City Mesa
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in the states of MA,CA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144. Class II Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations. 9 units Z-0902-2013