Recall Z-0066-2023 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
| Date | Oct 7, 2022 (initiated Jul 29, 2022) |
| Status | Open, Classified |
| Reason | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) |
| Root cause | Process control |
| Action | Hobbs Medical issued URGENT RECALL letter via Certified Mail with return receipt requested on 7/29/22. Letter states reason for recall, health risk and action to take: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to an |
| Quantity | 1 unit |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834351 | BILIARY INDWELLING STENT Hobbs Medical, Inc., Mar 22, 1984 |