BEUDAMED
    FDA Enforcement Class II Terminated

    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

    Recall: Z-2543-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2543-2020
    Event ID
    85803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 4, 2020
    Classification Date
    July 9, 2020
    Termination Date
    August 5, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

    Reason

    Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

    Code Info

    Model Numbers: 47-4000, Lot numbers:201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Canada.

    Quantity

    3000