BEUDAMED
    FDA Enforcement Class II Terminated

    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.

    Recall: Z-0164-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0164-2018
    Event ID
    78363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    August 10, 2017
    Classification Date
    November 21, 2017
    Termination Date
    April 24, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.

    Reason

    The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.

    Code Info

    Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.

    Distribution

    USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.

    Quantity

    1,428 units total