Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
FDA Recall #Z-0042-2023 — Class II — July 29, 2022
Product Description
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
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.)
Recalling Firm
Hobbs Medical, Inc. — Stafford Springs, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Code Information
UDI-DI: M84960280 Lot Numbers: H02-19-021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated