The Sarns Centrifugal Pump is a single use device recall
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be…
Why was The Sarns Centrifugal Pump is a single use device recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
TAOS, TC03
- Product
- The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 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
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)