BEUDAMED
    FDA Enforcement Class II Ongoing

    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

    Recall: Z-1355-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1355-2021
    Event ID
    87581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tenderneeds Fertility LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    April 14, 2021
    Initiation Date
    December 23, 2020
    Classification Date
    April 6, 2021
    Address
    10162 Bradford Rd, N/A, Greenville, IN, 47124-9227, United States

    Description

    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

    Reason

    Device was distributed without a proper marketing authorization.

    Code Info

    All lots

    Distribution

    World-wide distribution.

    Quantity

    Unknown