BEUDAMED
    FDA Enforcement Class II Ongoing

    Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

    Recall: Z-2182-2021 · Reported August 11, 2021

    Enforcement

    Recall Number
    Z-2182-2021
    Event ID
    88225
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tenderneeds Fertility LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    August 11, 2021
    Initiation Date
    December 23, 2020
    Classification Date
    August 2, 2021
    Address
    10162 Bradford Rd, Greenville, IN, 47124-9227, United States

    Description

    Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

    Reason

    Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

    Code Info

    All lots sold prior to December 9, 2019.

    Distribution

    Worldwide distribution.

    Quantity

    Unknown