Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation T...
FDA Recall #Z-2181-2021 — Class II — December 23, 2020
Product Description
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
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.
Recalling Firm
Tenderneeds Fertility LLC — Greenville, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Unknown
Distribution
Worldwide distribution.
Code Information
All lots sold prior to December 9, 2019.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated