Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
FDA Recall Z-2175-2021 · Posted None
Recalling FirmTenderneeds Fertility LLC
Recall StatusOpen, Classified
Product CodeMQF
Date Initiated2020-12-23
Product QuantityUnknown
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.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.