BEUDAMED
    FDA Enforcement Class II Ongoing

    Regard Kit containing the Microtek decanter

    Recall: Z-2685-2024 · Reported August 28, 2024

    Enforcement

    Recall Number
    Z-2685-2024
    Event ID
    94999
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2024
    Initiation Date
    June 17, 2024
    Classification Date
    August 16, 2024
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    Regard Kit containing the Microtek decanter

    Reason

    Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

    Code Info

    Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)

    Distribution

    US Nationwide distribution in the state of MO.

    Quantity

    78 Kits