Device product
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Z-1828-2015
Product summary
- Event
- Event 71196
- Status
- Terminated
- Classification
- Class II
- Quantity
- 163 devices
- Official record key
device-enforcement:Z-1828-2015
Official wording
Reason: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Code information: Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
Distribution pattern: Distributed to the states of MO and FL.
Derived failure modes
-
Unknown
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.