BEUDAMED
    FDA Recall Open, Classified

    ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

    Recall: Z-1420-2023 · Initiated March 20, 2023

    Recall

    Recall Number
    Z-1420-2023
    Event Number
    91888
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KYX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 20, 2023
    Posted
    April 20, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

    Reason

    ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

    Action

    Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/20/2023 by USPS. The notice explained the issue and the hazard and requested the following actions be taken: Immediately locate, isolate, and cease all use of the affected product. The product code and lot number can be found on the product carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001, 7:00 am and 6:00 pm Central Time, Monday - Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, contact Baxter s Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

    Distribution

    US

    Quantity

    91,100 units