BEUDAMED
    FDA Enforcement Class II Terminated

    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.

    Recall: Z-0272-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0272-2018
    Event ID
    78714
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 27, 2017
    Initiation Date
    December 1, 2017
    Classification Date
    December 21, 2017
    Termination Date
    September 27, 2018
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327, United States

    Description

    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.

    Reason

    3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.

    Code Info

    Lot 6285035. UDI: 00885825016661.

    Distribution

    Distributed to Texas.

    Quantity

    280 devices