FDA Enforcement
Class II
Ongoing
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Recall: Z-2179-2021
·
Reported August 11, 2021
Enforcement
- Recall Number
- Z-2179-2021
- Event ID
- 88225
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tenderneeds Fertility LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- August 11, 2021
- Initiation Date
- December 23, 2020
- Classification Date
- August 2, 2021
- Address
- 10162 Bradford Rd, Greenville, IN, 47124-9227, United States
Description
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Reason
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Code Info
All lots sold prior to December 9, 2019.
Distribution
Worldwide distribution.
Quantity
Unknown