Recall Z-0109-2008 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
| Date | Oct 31, 2007 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire. |
| Root cause | Packaging process control |
| Action | Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form |
| Quantity | 153 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000177 | RENEGADE HI-FLO MICROCATHETER Boston Scientific Corp, Apr 7, 2000 |