BEUDAMED
    FDA Recall Open, Classified

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

    Recall: Z-1578-2022 · Initiated July 22, 2022

    Recall

    Recall Number
    Z-1578-2022
    Event Number
    90658
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KYX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 22, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

    Reason

    There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

    Action

    Baxter notified its direct consignees by letter on 07/22/2022. The letter explained the issue and potential hazard and provided the following instructions: "1. Locate, isolate/quarantine, and prepare for return any unused affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return of the products and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. 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 consumer-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, please contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday."

    Distribution

    Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

    Quantity

    24,320 units