Medical device recalls Moderate risk

GA HEALTH COMPANY LIMITED recalls ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY…

Recall date
November 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0648-2021
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

ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

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