FDA-Device2020-12-30Class II

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

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
20,000 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
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0647-2021

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