Z-0010-2023 Class II Ongoing
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
- 275 units
Product Description
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
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
UD-DI: M84921900 Lot Numbers: H02-18-166R H02-18-167R H02-18-168R H02-18-169R H04-18-214R H11-17-182R