FDA recall Z-2181-2021

Tenderneeds Fertility LLC · Class II · device

Product

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.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2020-12-23
Report date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greenville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2021