BEUDAMED
    FDA Enforcement Class II Ongoing

    ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

    Recall: Z-1276-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1276-2024
    Event ID
    93896
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2024
    Initiation Date
    January 17, 2024
    Classification Date
    March 7, 2024
    Address
    7815 National Service Rd Ste 600, Greensboro, NC, 27409-9403, United States

    Description

    ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

    Reason

    The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

    Code Info

    Lot #2C02496, UDI-DI #00768455116096.

    Distribution

    Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.

    Quantity

    1,715 units