BEUDAMED
    FDA Recall Terminated

    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3

    Recall: Z-0578-2018 · Initiated December 27, 2017

    Recall

    Recall Number
    Z-0578-2018
    Event Number
    78899
    FEI Number
    1000049086
    Product Code
    KME
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 27, 2017
    Posted
    January 9, 2018
    Terminated
    July 30, 2018
    Address
    2273 Larsen Rd, LITTLE RAPIDS CORPORATION, Green Bay, WI, 54303-4809

    Description

    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3

    Reason

    The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.

    Action

    The firm initiated their recall by email on 12/27/2017 to their direct consignees. The consignees were directed to report back with the number of products on hand for return and to notify their customers of the recall.

    Distribution

    TX, CT, TN, MO, WI, FL, SD, MS, CA, MS

    Quantity

    153 cases, 30 units in each case