Home / Recalls / Medical Devices
GA HEALTH COMPANY LIMITED recalls STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUT
Recalled December 30, 2020 · FDA recall Z-0639-2021 · 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
12,800 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 Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
Manufacturer(s)
GA HEALTH COMPANY LIMITED
Made in
Hong Kong SAR
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →