GA HEALTH COMPANY LIMITED recalls STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN

Recalled December 30, 2020 · FDA recall Z-0642-2021 · 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

10,000

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 Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

Manufacturer(s)

GA HEALTH COMPANY LIMITED

Made in

Hong Kong SAR

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →