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GA HEALTH COMPANY LIMITED recalls STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGIC
Recalled December 30, 2020 · FDA recall Z-0641-2021 · GA HEALTH COMPANY
Hazard
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure · FDA Class II
Units
11,000 units
Sold at
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Description
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Product
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Manufacturer(s)
GA HEALTH COMPANY LIMITED
Made in
Hong Kong SAR
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →