Device product
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Z-2029-2014
Product summary
- Event
- Event 68024
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2029-2014
Official wording
Reason: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Code information: Lot No. RC07, QM03, QN07, and RA09.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.