Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Recall
- Recall Number
- Z-0902-2013
- Event Number
- 64383
- Firm
- Salyer Prn Biomedical
- FEI Number
- 3001589655
- Product Code
- DTQ
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- January 31, 2013
- Posted
- March 1, 2013
- Terminated
- April 15, 2013
- Address
- 1833 W Main St, Ste 116, Mesa, AZ, 85201-6924
Description
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232.
Distributed in the states of MA,CA, and WI.
9 units