Freeman Pancreatic Flexi-Stent Catalog Number: 6535

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: M84965350 Lot Numbers: H01-16-055R

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