Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
FDA Recall #Z-0050-2023 — Class II — July 29, 2022
Product Description
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
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: M84965030 Lot Numbers: H05-20-155 H06-20-022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.