BEUDAMED
    FDA Enforcement Class II Terminated

    3,65 m Extension Set with Luer-lock Connector

    Recall: Z-1145-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1145-2022
    Event ID
    90032
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    April 21, 2022
    Classification Date
    May 27, 2022
    Termination Date
    May 27, 2026
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    3,65 m Extension Set with Luer-lock Connector

    Reason

    Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

    Code Info

    Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)

    Distribution

    US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

    Quantity

    60 units