BEUDAMED
    FDA Enforcement Class II Terminated

    Isolation Droplet Bundle Kit

    Recall: Z-2465-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2465-2020
    Event ID
    85736
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2020
    Initiation Date
    May 19, 2020
    Classification Date
    June 26, 2020
    Termination Date
    September 1, 2020
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Isolation Droplet Bundle Kit

    Reason

    Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

    Code Info

    Item: 830006013, Lot #: 78253M

    Distribution

    Domestic distribution only to: MO and LA.

    Quantity

    24 kits