Device product
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
Z-0043-2023
Product summary
- Event
- Event 90769
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0043-2023
Official wording
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.)
Code information: UDI-DI: M84961040 Lot Numbers: H11-17-020R
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Derived failure modes
-
Labeling or packaging
label display an incorrect