Recall Z-2175-2021— Tenderneeds Fertility LLC

Name: FDA recall Z-2175-2021
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: Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001. 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

Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

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.