—#68042

Product

Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.

FDA product code: DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K982891
Affected lot / code info: Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.

Why it was recalled

A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.

Timeline

Recall initiated: 2008-02-05
Posted by FDA: 2009-08-04
Terminated: 2009-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68042. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.