Medical device recalls Moderate risk

GA HEALTH COMPANY LIMITED recalls Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diver…

Recall date
November 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0647-2021
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

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

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