Recall Z-0303-2012
Terumo Cardiovascular Systems Corporation · initiated October 21, 2011
Product
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
Codes / lots: Catalog Number 16422 Serial Number 1901
Reason for recall
Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
FDA-determined cause: Employee error
Action taken
Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.
Details
- Recall number
- Z-0303-2012
- Initiated
- October 21, 2011
- Posted by FDA
- November 29, 2011
- Terminated
- February 17, 2012
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Quantity
- 10 units
- Distribution
- Nationwide Distribution (USA) including the state of San Antonio, TX
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI