BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    Recall: Z-0806-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0806-2018
    Event ID
    79090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    February 6, 2018
    Classification Date
    March 1, 2018
    Termination Date
    April 2, 2021
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    Reason

    Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

    Code Info

    Lot No. 1203395, Expiration Date 11/30/2019

    Distribution

    Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

    Quantity

    2,800 units