Recall Z-0560-2020 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
| Date | Nov 25, 2019 (initiated Oct 21, 2019) |
| Status | Terminated |
| Reason | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life |
| Root cause | Incorrect or no expiration date |
| Action | Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. |
| Quantity | 35 units |
| Distribution | Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133700 | ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS Boston Scientific Corporation, May 14, 2014 |