GA HEALTH COMPANY LIMITED recalls STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8…

Recall date

November 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0641-2021

FDA classification

Class II

Brand / firm

GA HEALTH COMPANY LIMITED

Sold / distributed

US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Why it was recalled

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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