BEUDAMED
    FDA Enforcement Class II Terminated

    Arjo Disposable Repositioning Sling, Model AHD001

    Recall: Z-2470-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2470-2021
    Event ID
    88403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge Dominican Republic SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    July 30, 2021
    Classification Date
    September 13, 2021
    Termination Date
    August 11, 2023
    Address
    Building 9 Piisa Industrial Park, Km. 18 1/2 Antigua Carretera Sanchez, Itabo, Haina, N/A, N/A, Dominican Republic (the)

    Description

    Arjo Disposable Repositioning Sling, Model AHD001

    Reason

    Sling loop straps on device pose a trip hazard.

    Code Info

    Model Number AHD001; Lots DAG1300482, DAG1300483, DAG1300484, DAG1300485, DAG1300486, DAG1300487, DBG1300488, DBG1300489, DBG1300490, DBG1300491, DBG1300492, DBG1300493, DBG1300494, DBG1300495, DBG1300496, DBG1300497, DBG1300498, DBG1300499, DCG1300500,, DCG1300501, DCG1300502, DCG1300503, DCG1300504, DCG1300505, DCG1300506, DCG1300507, DCG1300508, DCG1300509, DCG1300510, DCG1300511, DCG1300513 DCG1300514, DCG1300515, DDG1300516, DDG1300517, DDG1300518, DDG1300519, DDG1300520, DDG1300521, DAG1300522, DDG1300523, DDG1300524, DDG1300525, DDG1300526, DEG1300527, DEG1300528, DEG1300529, DEG1300530, DEG1300531, DEG1300532, DEG1300533, DEG1300534, DEG1300535, DEG1300536, DFG1300537

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, VT, WI, and WV.

    Quantity

    46,085 units