Recall Z-2673-2017 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
| Date | Jun 1, 2017 |
| Status | Terminated |
| Reason | Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon |
| Root cause | Employee error |
| Action | Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check 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 as a method of documenting the presence or absence of affected product from their inventory. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 BSCFieldActionCenter@bsci.com. |
| Quantity | 39 units |
| Distribution | MI, MO Foreign: Austria France Great Britain Italy Spain Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.