BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0578-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0578-2018
    Event ID
    78899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LITTLE RAPIDS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    December 27, 2017
    Classification Date
    February 9, 2018
    Termination Date
    July 30, 2018
    Address
    2273 Larsen Rd, Green Bay, WI, 54303-4809, United States

    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.

    Code Info

    Lot codes: 17871, 17971, 18071, and 18971

    Distribution

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

    Quantity

    153 cases, 30 units in each case