The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in
FDA device recall Z-1235-2017 · posted 2017-02-22 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
- Action taken
- Customer Notification Letter/Response Form is being sent to all affected consignees.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 579 units have entered into the distribution chain
- Distribution
- Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
- Date initiated
- 2015-05-27
- Date posted
- 2017-02-22
- Date terminated
- 2017-02-23
- Location
- Elkton, MD
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARN CENTRIFUGAL PUMP (K112229) | Terumo Cardiovascular Systems | 2011-12-09 |