Tenderneeds Fertility LLC recalls Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Recalled August 11, 2021 · FDA recall Z-2178-2021 · 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

Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Manufacturer(s)

Tenderneeds Fertility LLC

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