Tenderneeds Fertility LLC recalls Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
- Recall date
- December 23, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2176-2021
- FDA classification
- Class II
- Brand / firm
- Tenderneeds Fertility LLC
- Sold / distributed
- Worldwide distribution.
Why it was recalled
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
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