FDA-Device2021-08-11Class II
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Tenderneeds Fertility LLC
Hazard
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Sold states
Worldwide distribution.
Affected count
Unknown
Manufactured in
10162 Bradford Rd, Greenville, IN, United States
Products
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2021Don't want to check this manually?
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