BEUDAMED
    FDA Recall Open, Classified

    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)

    Recall: Z-1356-2021 · Initiated December 23, 2020

    Recall

    Recall Number
    Z-1356-2021
    Event Number
    87581
    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

    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)

    Reason

    Device was distributed without a proper marketing authorization.

    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.

    Distribution

    World-wide distribution.

    Quantity

    Unknown