Home / Recalls / Salyer Prn Biomedical / Z-0902-2013

Z-0902-2013 Class II Terminated

Recalled by Salyer Prn Biomedical — Mesa, AZ

Recall Details

Product Type: Devices
Report Date: March 13, 2013
Initiation Date: January 31, 2013
Termination Date: April 15, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 units

Product Description

Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

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.

Distribution Pattern

Distributed in the states of MA,CA, and WI.

Code Information

Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.