Recall Z-2046-2009 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
| Date | Aug 4, 2009 (initiated Feb 5, 2008) |
| Status | Terminated |
| Reason | 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 | Process control |
| 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. |
| Quantity | 7079 |
| Distribution | Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc., Sep 30, 1998 |