PlainRecalls
FDA Devices Moderate Class II Ongoing

Freeman Pancreatic Flexi-Stent Catalog Number: 6548

Reported: October 19, 2022 Initiated: July 29, 2022 #Z-0059-2023

Product Description

Freeman Pancreatic Flexi-Stent Catalog Number: 6548

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.)

Details

Recalling Firm
Hobbs Medical, Inc.
Units Affected
10 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Location
Stafford Springs, CT

Frequently Asked Questions

What product was recalled?
Freeman Pancreatic Flexi-Stent Catalog Number: 6548. Recalled by Hobbs Medical, Inc.. Units affected: 10 units.
Why was this product recalled?
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.)
Which agency issued this recall?
This recall was issued by the FDA Devices on October 19, 2022. Severity: Moderate. Recall number: Z-0059-2023.