BEUDAMED
    FDA Enforcement Class II Terminated

    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.

    Recall: Z-2326-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2326-2012
    Event ID
    58247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Breg Inc, An Orthofix Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 12, 2012
    Initiation Date
    August 11, 2010
    Classification Date
    September 6, 2012
    Termination Date
    September 6, 2012
    Address
    2885 Loker Ave E, N/A, Carlsbad, CA, 92010-6626, United States

    Description

    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.

    Reason

    This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.

    Code Info

    Lot # D101564

    Distribution

    Worldwide distribution: USA (nationwide) and country of: Nova Scotia.

    Quantity

    502 units