BEUDAMED
    FDA Recall 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 · Initiated December 1, 2017

    Recall

    Recall Number
    Z-0272-2018
    Event Number
    78714
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 1, 2017
    Terminated
    September 27, 2018
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    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.

    Action

    An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued.

    Distribution

    Distributed to Texas.

    Quantity

    280 devices