medical Class II Updated 2021-08-11

Tenderneeds Fertility LLC recalls Deluxe At-Home Human Artificial Intracervical (ICI) Insemina

Recalled Product

Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: All lots sold prior to December 9, 2019.
View official government recall

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