FDA Recall
Terminated
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Recall: Z-2046-2009
·
Initiated February 5, 2008
Recall
- Recall Number
- Z-2046-2009
- Event Number
- 46722
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- DTS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 5, 2008
- Posted
- August 4, 2009
- Terminated
- November 1, 2009
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586
Description
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Reason
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
Action
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.
Distribution
Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
Quantity
7079