BEUDAMED
    FDA Recall Terminated

    BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

    Recall: Z-1109-2021 · Initiated December 23, 2020

    Recall

    Recall Number
    Z-1109-2021
    Event Number
    87158
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 23, 2020
    Terminated
    November 21, 2022
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

    Reason

    The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.

    Action

    On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.

    Distribution

    Distribution US nationwide and Canada

    Quantity

    155,200 needles