Hobbs Medical, Inc. Recall 90769
Description: Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
Hobbs Medical, Inc. Recall 90769 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0054-2023 |
| Event ID | 90769 |
| Event Description | Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway. |
| Quantity | 4 units |
| Recall 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.) |
| Device Classification | 20221019 |
| Device Code Info | UDI-DI: M84965290 Lot Numbers: H08-18-117 H08-18-192 |
| Center Classification Date | 20221007 |
| Recall Initiation Date | 20220729 |
| Recalling Firm | Hobbs Medical, Inc. |
| Initial Notification | Letter |
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