BEUDAMED
    FDA Enforcement Class II Terminated

    CVC BUNDLE, 20CM, 3L, PI ECVC5120A

    Recall: Z-0092-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0092-2020
    Event ID
    83584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    April 24, 2019
    Classification Date
    October 9, 2019
    Termination Date
    April 3, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    CVC BUNDLE, 20CM, 3L, PI ECVC5120A

    Reason

    Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

    Code Info

    2018032350 2018081050 2018091950 2018112750 2018121850 2019012450 2019013050

    Distribution

    Nationwide domestic distribution.

    Quantity

    181965 total