FDA-Device2020-12-30Class II
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
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
93,700 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-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2021Don't want to check this manually?
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