Recall Z-1102-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corp
Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
| Date | Jul 20, 2004 (initiated Jun 18, 2004) |
| Status | Terminated |
| Reason | Mislabeled as to length; 10 cm length labeled as 5 cm. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock. |
| Distribution | California, Hawaii, Kentucky, New Jersey and Oregon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834468 | DRAINAGE STENT Microvasive, Apr 20, 1984 |