Z-0049-2023 Class II Ongoing
FDA device recall Z-0049-2023 was initiated by Hobbs Medical, Inc. on July 29, 2022 and is designated Class II. Reason for recall: 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-… The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2022
- Initiation Date
- July 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Reason for Recall
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.)
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Code Information
UDI-DI: M84965010 Lot Numbers: H09-18-008