FDA-Device2020-12-30Class II

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

GA HEALTH COMPANY LIMITED
Hazard

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

Sold states
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Affected count
50 units
Manufactured in
Unit 18, 21/F, Metropole Square; 2 On Yiu Street ,Shatin, N.T, Shatin N.T., N/A, Hong Kong SAR
Products
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0645-2021

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