Recall Z-0902-2013— Salyer Prn Biomedical
Class II · Terminated
Class II FDA medical device recall by Salyer Prn Biomedical, initiated 2013-01-31, terminated 2013-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.. Reason: Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations..
- Recalling firm
- Salyer Prn Biomedical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-31
- Terminated
- 2013-04-15
- Firm location
- Mesa, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.