Recall Z-2958-2020 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
| Date | Aug 7, 2020 |
| Status | Terminated |
| Reason | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device |
| Root cause | Packaging process control |
| Action | Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required on July 31, 2020, via BSC Sales Representatives. The Sales Representatives contacted accounts to determine whether or not the affected inventory had been used. If the product was not used at the site, the product was quarantined. Additionally, customer notification letters to the 32 consignees were sent via Federal Express Priority Overnight mail on July 31st, 2020. Letter states reason for recall, health risk and action to take: Your local Boston Scientific sales representative is available to support this rem |
| Quantity | 40 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140630 | WALLFLEX BILIARY RX STENT SYSTEM Boston Scientific, May 23, 2014 |