BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E

    Recall: Z-1159-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1159-2023
    Event ID
    91560
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 1, 2023
    Initiation Date
    November 18, 2022
    Classification Date
    February 22, 2023
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E

    Reason

    Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

    Code Info

    UDI-DI: 50195594389336(ea) 10195594389338(cs) Lot Number: 818636 Exp. Date: 3/1/2024

    Distribution

    US Nationwide distribution in the states of GA, PA.

    Quantity

    31,300 EA