Medical device recalls Moderate risk

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

Recall date
December 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2180-2021
FDA classification
Class II
Brand / firm
Tenderneeds Fertility LLC
Sold / distributed
Worldwide distribution.

Why it was recalled

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

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

What was recalled

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

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