BEUDAMED
    FDA Enforcement Class I Terminated

    Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

    Recall: Z-1653-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1653-2022
    Event ID
    90730
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    September 21, 2022
    Initiation Date
    August 9, 2022
    Classification Date
    September 9, 2022
    Termination Date
    August 9, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

    Reason

    Firm noted an increase in customer reports of leaks.

    Code Info

    UDI/DI 00085412656649, All lots within expiry

    Distribution

    US Nationwide Distribution

    Quantity

    511,728 units