FDAFDA · Food and drugs·Recall number Z-2178-2021
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Published August 11, 2021 · Recall initiated: December 23, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Tenderneeds Fertility LLC
- Distributor
- Worldwide distribution.
- Lot
- All lots sold prior to December 9, 2019.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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