BEUDAMED
    FDA Recall Terminated

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Recall: Z-0948-2022 · Initiated February 25, 2022

    Recall

    Recall Number
    Z-0948-2022
    Event Number
    89682
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KYX
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 25, 2022
    Terminated
    March 2, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Reason

    Product is mislabeled as self-righting Luer slip tip caps, yellow.

    Action

    The recalling firm issued letters dated 2/25/2022 via first class mail to the U.S. consignees. The letter explained the reason for recall, described the affected product, the hazard involved, and the actions to be taken by the customer. Those actions included to immediately check their inventory and segregate the affected product, which had a notation that if there are Luer lock tip caps co-mingled with Luer slip tip caps in the same DISCPAC container, please discard the DISCPAC container and that tip caps that are not co-mingled can continue to be used safely following good pharmacy practices. If the consignee received the letter directly from Baxter, they are to acknowledge receipt by responding on the customer portal. If the product was purchased from a distributor, they only need to respond to the distributor or wholesaler according to their instructions. If the product was further distributed to other facilities or departments within their institution, they were instructed to forward a copy of the letter to them. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer that distributed the affected product to other facilities, they are to distribute the notification to them. A Reply Form Instruction Sheet was enclosed which outlined the details of the affected product and Baxter Field Action Portal Acknowledgement Instructions. Notification of OUS consignees began 2/25/2022 via mail, email, or FAX.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.

    Quantity

    5,500 DISCPACs (100/DISCPAC).