FDA recall Z-0010-2023

Hobbs Medical, Inc. · Class II · device

Product

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

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

Key facts

Status: Ongoing
Initiation date: 2022-07-29
Report date: 2022-10-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Stafford Springs, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2023