BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1122-2019 · Initiated March 7, 2019

    Recall

    Recall Number
    Z-1122-2019
    Event Number
    82317
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 7, 2019
    Terminated
    May 12, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    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.

    Action

    Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers.

    Distribution

    US distribution to the states of FL and NJ.

    Quantity

    6,509,600