Z-0902-2013 Class II Terminated
FDA device recall Z-0902-2013 was initiated by Salyer Prn Biomedical on January 31, 2013 and is designated Class II. 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. The recall status is terminated (terminated April 15, 2013). Affected quantity: 9 units.
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.