Recall Z-0358-2011 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland
| Date | Nov 15, 2010 (initiated Aug 24, 2009) |
| Status | Terminated |
| Reason | Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection. |
| Root cause | Packaging process control |
| Action | Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734. |
| Distribution | Distribution Worldwide, including throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973645 | RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific Corp, Nov 19, 1997 |