PlainRecalls
FDA Devices Moderate Class II Ongoing

Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

Reported: August 11, 2021 Initiated: December 23, 2020 #Z-2176-2021

Product Description

Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

Reason for Recall

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Details

Recalling Firm
Tenderneeds Fertility LLC
Units Affected
Unknown
Distribution
Worldwide distribution.
Location
Greenville, IN

Frequently Asked Questions

What product was recalled?
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt. Recalled by Tenderneeds Fertility LLC. Units affected: Unknown.
Why was this product recalled?
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 11, 2021. Severity: Moderate. Recall number: Z-2176-2021.