FDA-Device2020-12-30Class II
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
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
100,000 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
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief