BEUDAMED
    FDA Enforcement Class II Terminated

    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

    Recall: Z-1122-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1122-2019
    Event ID
    82317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    March 7, 2019
    Classification Date
    April 10, 2019
    Termination Date
    May 12, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

    Reason

    The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.

    Code Info

    Lot Numbers, UDI: 18041501, (17)210315(10)18041501, (01)50885403235915. 18042501, (17)210325(10)18042501, (01)50885403235915. 18050501, (17)210405(10)18050501, (01)50885403235915. 18051501, (17)210415(10)18051501, (01)50885403235915. 18052501, (17)210425(10)18052501, (01)50885403235915. 18060501, (17)210505(10)18060501, (01)50885403235915. 18061501, (17)210515(10)18061501, (01)50885403235915. 18062501, (17)210525(10)18062501, (01)50885403235915. 18070501, (17)210605(10)18070501, (01)50885403235915. 18072501, (17)210625(10)18072501, (01)50885403235915. 18080501, (17)210705(10)18080501, (01)50885403235915. 18081501, (17)210715(10)18081501, (01)50885403235915.

    Distribution

    US distribution to the states of FL and NJ.

    Quantity

    6,509,600