Recall Z-0603-2014 ยท MNJ Valve, Pressure Relief, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
| Date | Dec 27, 2013 (initiated Jun 4, 2013) |
| Status | Terminated |
| Reason | Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 24,227. |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820297 | WM. HARVEY OVERPRESSURE SAFETY VALVE C.R. Bard, Inc., Mar 12, 1982 |