BEUDAMED
    FDA Recall Terminated

    EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

    Recall: Z-2432-2019 · Initiated June 27, 2019

    Recall

    Recall Number
    Z-2432-2019
    Event Number
    83230
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KYX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2019
    Terminated
    November 2, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

    Reason

    EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

    Action

    The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes.

    Distribution

    Nationwide

    Quantity

    2192000 syringes