BEUDAMED
    FDA Enforcement Class II Ongoing

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    Recall: Z-0315-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0315-2024
    Event ID
    93204
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 22, 2023
    Initiation Date
    September 21, 2023
    Classification Date
    November 16, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    Reason

    Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

    Code Info

    a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

    Distribution

    MO

    Quantity

    134 units