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Tenderneeds Fertility LLC recalls Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Recalled August 11, 2021 · FDA recall Z-2182-2021 · 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
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Manufacturer(s)
Tenderneeds Fertility LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →