Medical device recalls Moderate risk

GA HEALTH COMPANY LIMITED recalls Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GA…

Recall date
November 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0645-2021
FDA classification
Class II
Brand / firm
GA HEALTH COMPANY LIMITED
Sold / distributed
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Why it was recalled

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

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

What was recalled

Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

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