medical Class II Updated 2021-08-11

Tenderneeds Fertility LLC recalls Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: All lots sold prior to December 9, 2019.
View official government recall

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