BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

    Recall: Z-0863-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0863-2020
    Event ID
    84693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Healthcare Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 5, 2020
    Initiation Date
    December 20, 2019
    Classification Date
    January 24, 2020
    Termination Date
    August 1, 2022
    Address
    4205 Eubank Rd, N/A, Richmond, VA, 23231-4328, United States

    Description

    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

    Reason

    A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.

    Code Info

    LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614

    Distribution

    US Distribution to IL.

    Quantity

    240 kits