BEUDAMED
    FDA Enforcement Class II Terminated

    Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.

    Recall: Z-1516-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1516-2015
    Event ID
    70838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PhotoMedex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 26, 2015
    Classification Date
    April 23, 2015
    Termination Date
    August 18, 2015
    Address
    100 Lakeside Dr, Horsham, PA, 19044-2316, United States

    Description

    Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.

    Reason

    The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.

    Code Info

    Item No. Description GCICK Iamin After-Care Kit GC044-1 Iamin Moist Dressing (1) GCIMD Iamin Moist Dressing Kit (7) GCIHG Iamin Hydrating Gel Kit M40329 Iamin Hydrating Gel 15g 20920. Insert, Iamin Care 6 x 4 20939. Iamin Kit Box (GCICK/GCICK) P-GCI624A Iamin Patient Brochure (25) PK PNI-624A Iamin Detail Brochure (25) PK

    Distribution

    Nationwide and Internationally, including Canada.

    Quantity

    200188