BEUDAMED
    FDA Enforcement Class II Terminated

    Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

    Recall: Z-2165-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2165-2013
    Event ID
    66082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxa Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    August 22, 2013
    Classification Date
    September 6, 2013
    Termination Date
    August 19, 2016
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

    Reason

    Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.

    Code Info

    Lot or Serial No. 785518

    Distribution

    Distributed to One Customer in NC.

    Quantity

    34 cases