BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1578-2022
    Event ID
    90658
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 22, 2022
    Classification Date
    August 25, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    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.

    Code Info

    a) 25 pack REF H938693025, UDI 00085412479965, ALL LOTS; b) 100 pack REF H938673100, UDI 00085412479798, ALL LOTS

    Distribution

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

    Quantity

    24,320 units