FDAClass IIOctober 19, 2022

Hobbs Biliary Pigtail Stent Kits recall

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

Why was Hobbs Biliary Pigtail Stent Kits 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: M84960010 Lot Numbers: H01-19-234 H01-19-230

Product
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Recalling firm
Hobbs Medical, Inc.
Quantity
3 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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