Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
This recall has been terminated (originally issued July 11, 2014).
- Recall Initiated
- April 14, 2014
- Posted
- July 11, 2014
- Terminated
- September 7, 2016
- Recall Number
- Z-2029-2014
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Distribution
Nationwide Distribution
Lot / Code Info
Lot No. RC07, QM03, QN07, and RA09.
Root Cause
Device Design
Action Taken
Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.