—#126809

Product

Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

FDA product code: KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K112229
Affected lot / code info: Lot No. RC07, QM03, QN07, and RA09.

Why it was recalled

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-04-14
Posted by FDA: 2014-07-11
Terminated: 2016-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.