FDA-Device2021-08-11Class II

Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

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
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2021

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