FDAClass IIOctober 19, 2022

Freeman Pancreatic Flexi-Stent Kit recall

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

Why was Freeman Pancreatic Flexi-Stent Kit 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: M84963520 Lot Numbers: H04-18-014R

Product
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
Recalling firm
Hobbs Medical, Inc.
Quantity
14 units
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)
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