Recall Z-2046-2009
Terumo Cardiovascular Systems Corporation · initiated February 5, 2008
Product
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Codes / lots: Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.
Reason for recall
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2046-2009
- Initiated
- February 5, 2008
- Posted by FDA
- August 4, 2009
- Terminated
- November 1, 2009
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Quantity
- 7079
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI