Tenderneeds Fertility LLC recalls Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

Recalled August 11, 2021 · FDA recall Z-2175-2021 · Tenderneeds Fertility

Hazard

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

Units

Unknown

Sold at

Worldwide distribution.

Description

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

Product

Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

Manufacturer(s)

Tenderneeds Fertility LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →