Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
This recall has been terminated (originally issued December 27, 2013).
- Recall Initiated
- June 4, 2013
- Posted
- December 27, 2013
- Terminated
- October 1, 2014
- Recall Number
- Z-0603-2014
- Quantity
- 24,227.
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Distribution
Nationwide Canada
Root Cause
Component design/selection
Action Taken
Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.