BEUDAMED
    FDA Enforcement Class II Terminated

    ReliaMed¿ 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-2720-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2720-2016
    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¿ 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

    51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137

    Distribution

    OH

    Quantity

    29,204 cartons