FDA recall Z-1364-2021
Tenderneeds Fertility LLC · Class II · device
Product
Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
Reason for recall
Device was distributed without a proper marketing authorization.
Distribution
World-wide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2020-12-23
- Report date
- 2021-04-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Greenville, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2021