BEUDAMED
    FDA Enforcement Class II Terminated

    APD Drain Manifold

    Recall: Z-1146-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1146-2022
    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

    APD Drain Manifold

    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: R5C4512; UDI: 00085412008790; Lot Number: H18D03030 (exp. date: 04/03/2023), Lot Number: H18E31046 (exp. date: 05/31/2023), Lot Number: H18L04065 (exp. date:12/04/2023), Lot Number: H20H10073 (exp. date: 08/10/2022)

    Distribution

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

    Quantity

    180 units