BEUDAMED
    FDA Enforcement Class II Ongoing

    Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

    Recall: Z-0047-2023 · Reported October 19, 2022

    Enforcement

    Recall Number
    Z-0047-2023
    Event ID
    90769
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hobbs Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2022
    Initiation Date
    July 29, 2022
    Classification Date
    October 7, 2022
    Address
    8 Spring St, N/A, Stafford Springs, CT, 06076-1505, United States

    Description

    Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

    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 Info

    UDI-DI:M84963510 Lot Numbers: H12-16-175R

    Distribution

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

    Quantity

    8 units