Recall Z-0664-03 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Sarns MP4 Cardioplegia Sets; catalog number 15501.
| Date | Mar 20, 2003 (initiated Feb 25, 2003) |
| Status | Terminated |
| Reason | There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery. |
| Root cause | Other |
| Action | Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers. |
| Quantity | 300 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.