BEUDAMED
    FDA Enforcement Class II Ongoing

    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

    Recall: Z-1122-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1122-2021
    Event ID
    87150
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2021
    Initiation Date
    December 30, 2020
    Classification Date
    February 16, 2021
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

    Reason

    complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

    Code Info

    UDI 07332414112394, All lots within expiry

    Distribution

    Worldwide distribution.

    Quantity

    57825 devices