BEUDAMED
    FDA Enforcement Class II Terminated

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    Recall: Z-1295-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1295-2022
    Event ID
    90302
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 6, 2022
    Initiation Date
    May 20, 2022
    Classification Date
    June 28, 2022
    Termination Date
    May 2, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    Reason

    A nonsterile component was packaged in a sterile convenience kit.

    Code Info

    Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.

    Distribution

    US Nationwide distribution in the state of FL.

    Quantity

    180 kits