Recall Z-0054-2012
Terumo Cardiovascular Systems Corporation · initiated September 13, 2011
Product
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
Codes / lots: Catalog number 11009010
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0054-2012
- Initiated
- September 13, 2011
- Posted by FDA
- October 17, 2011
- Terminated
- December 10, 2012
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Quantity
- 5700
- Distribution
- Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0053-2012 | Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with…Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the… | 09/13/2011Terminated |