Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Company
- Tenderneeds Fertility Llc
- Recall Initiated
- December 23, 2020
- Recall Number
- Z-2181-2021
- Quantity
- Unknown
- Firm Location
- Greenville, IN
Reason for Recall
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Distribution
Worldwide distribution.
Lot / Code Info
All lots sold prior to December 9, 2019.
Root Cause
No Marketing Application
Action Taken
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.