FDA-Device2022-10-19Class II

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

Hobbs Medical, Inc.
Hazard

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.)

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Affected count
2 units
Manufactured in
8 Spring St, N/A, Stafford Springs, CT, United States
Products
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2023

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