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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

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

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 Letter
Distribution Pattern Distributed in the states of MA,CA, and WI.