BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0806-2018 · Initiated February 6, 2018

    Recall

    Recall Number
    Z-0806-2018
    Event Number
    79090
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KYZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 6, 2018
    Terminated
    April 2, 2021
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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).

    Action

    Customers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distributed. Questions and concerns can be directed to the Public Contact, Center for One Baxter with phone number (Toll Free) 800-422-9837 and 847-948-4770, Monday through Friday 8:00 AM to 5:00 PM CST.

    Distribution

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

    Quantity

    2,800 units