Tenderneeds Fertility LLC recalls At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205…

Recall date

December 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1355-2021

FDA classification

Class II

Brand / firm

Tenderneeds Fertility LLC

Sold / distributed

World-wide distribution.

Why it was recalled

Device was distributed without a proper marketing authorization.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)