FDA-Device2021-08-11Class II
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
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
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2180-2021Don't want to check this manually?
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