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

Reason: 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.)

Code information: UDI-DI: M84960010 Lot Numbers: H01-19-234 H01-19-230

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.