Medical device recalls Moderate risk

Tenderneeds Fertility LLC recalls Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

Recall date
December 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1362-2021
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

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

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