Z-2178-2021 Class II Ongoing
FDA device recall Z-2178-2021 was initiated by Tenderneeds Fertility LLC on December 23, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: Unknown.
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- December 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
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 Pattern
Worldwide distribution.
Code Information
All lots sold prior to December 9, 2019.