Recall Z-1192-03 ยท 74D
Terumo Cardiovascular Systems Corp
Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578
| Date | Aug 29, 2003 (initiated Aug 8, 2003) |
| Status | Terminated |
| Reason | Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility. |
| Root cause | Other |
| Action | Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo. |
| Distribution | United States, Canada, Chile, China, Germany and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925442 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns, May 21, 1993 |