BEUDAMED
    FDA Recall Open, Classified

    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

    Recall: Z-2181-2021 · Initiated December 23, 2020

    Recall

    Recall Number
    Z-2181-2021
    Event Number
    88225
    Firm
    Tenderneeds Fertility LLC
    FEI Number
    3012228225
    Product Code
    MQF
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    December 23, 2020
    Address
    10162 Bradford Rd, Greenville, IN, 47124-9227

    Description

    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

    Reason

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

    Action

    On December 23, 2020, the firm published a recall notification on its website at the following URL: https://tenderneedsfertility.com/recalls. The notification notified customers that all IUI and ICI kits sold for human use were being recalled. Customers were instructed to destroy these products, including leftover portions, immediately. The firm did not ask customers to return the product. This event was previously recorded under RES 87851. On June 9, 2021, firm updated recall communication on website to include more information about the recall. All IUI and ICI kits sold for human use by the firm prior to December 9, 2019 are subject to the recall. Some of the products listed in the notice were not previously captured by FDA's summary. This event (RES 88225) was created to document these additional products.

    Distribution

    Worldwide distribution.

    Quantity

    Unknown