Recall Z-0177-2007 ยท KRA Catheter, Continuous Flush
Boston Scientific Target
Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
| Date | Nov 14, 2006 (initiated Oct 13, 2006) |
| Status | Terminated |
| Reason | Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct) |
| Root cause | Other |
| Action | On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return. |
| Quantity | 54 units |
| Distribution | Class III Recall-Worldwide-USA and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973645 | RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific Corp, Nov 19, 1997 |