BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0164-2018 · Initiated August 10, 2017

    Recall

    Recall Number
    Z-0164-2018
    Event Number
    78363
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    IKX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 10, 2017
    Terminated
    April 24, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    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.

    Action

    Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed. Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.

    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