BEUDAMED
    FDA Enforcement Class II Terminated

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    Recall: Z-1901-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1901-2020
    Event ID
    84741
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Delfi Medical Innovations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2020
    Initiation Date
    April 3, 2019
    Classification Date
    May 5, 2020
    Termination Date
    July 22, 2022
    Address
    1099 8th Ave W Suite 106, N/A, Vancouver, N/A, N/A, Canada

    Description

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    Reason

    Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.

    Code Info

    18J17

    Distribution

    US: Ohio OUS: Austrailia

    Quantity

    59 units