Freeman Pancreatic Flexi-Stent recall
Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
Why was Freeman Pancreatic Flexi-Stent 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.)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: M84965840 Lot Numbers: H07-16-033R Kit Lot Number: H09-18-008
- Product
- Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
- Recalling firm
- Hobbs Medical, Inc.
- Quantity
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)