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FDAFDA · Food and drugs·Recall number Z-0648-2021

ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

Published December 30, 2020 · Recall initiated: November 3, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GA HEALTH COMPANY LIMITED
Distributor
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Lot
Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384
Risk classification
Class II
Area (FDA)
device
Country
Hong Kong SAR

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