Device product
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Z-0603-2014
Product summary
- Event
- Event 67064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,227.
- Official record key
device-enforcement:Z-0603-2014
Official wording
Reason: Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Code information: Unavailable
Distribution pattern: Nationwide Canada
Derived failure modes
-
Unknown
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.