BEUDAMED
    FDA Enforcement Class II Terminated

    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.

    Recall: Z-2719-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2719-2016
    Event ID
    75033
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Medical Solutions Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2016
    Initiation Date
    January 15, 2015
    Classification Date
    September 2, 2016
    Termination Date
    November 23, 2016
    Address
    Premier Park 33, Road One, Windford Industrial Estate, Winsford, N/A, United Kingdom

    Description

    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.

    Reason

    On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

    Code Info

    AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256

    Distribution

    OH

    Quantity

    47,569 cartons