Recall Z-0122-2007 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
| Date | Nov 1, 2006 (initiated Aug 10, 2005) |
| Status | Terminated |
| Reason | Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04 |
| Root cause | Other |
| Action | Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled. |
| Quantity | 5 units |
| Distribution | TX, KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000177 | RENEGADE HI-FLO MICROCATHETER Boston Scientific Corp, Apr 7, 2000 |