Device product
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0011-2023
Product summary
- Event
- Event 90769
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0011-2023
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: M84921910 Lot Numbers: H03-16-015R
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