BEUDAMED
    FDA Enforcement Class II Terminated

    regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

    Recall: Z-0411-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0411-2022
    Event ID
    89078
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 29, 2021
    Initiation Date
    November 4, 2021
    Classification Date
    December 22, 2021
    Termination Date
    August 7, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

    Reason

    The kit contains a non-sterile needle.

    Code Info

    Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.

    Distribution

    Distribution was made to Missouri. There was no foreign/military/government distribution.

    Quantity

    40 kits