Recall Z-0054-2012 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
| Date | Oct 17, 2011 (initiated Sep 13, 2011) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818. |
| Quantity | 5700 |
| Distribution | Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.