Recall Z-2180-2021— Tenderneeds Fertility LLC

Name: FDA recall Z-2180-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-23

Class II · Ongoing

Class II FDA medical device recall by Tenderneeds Fertility LLC, initiated 2020-12-23. FDA's recall record names no specific 510(k) clearance for this event. Product: TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771. Reason: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021..

Recalling firm: Tenderneeds Fertility LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-12-23
Firm location: Greenville, IN, United States

Product description

TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.