PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 30, 2020 Initiated: November 3, 2020 #Z-0648-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
GA HEALTH COMPANY LIMITED
Units Affected
100,000 units
Distribution
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Location
Shatin N.T., N/A

Frequently Asked Questions

What product was recalled?
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1. Recalled by GA HEALTH COMPANY LIMITED. Units affected: 100,000 units.
Why was this product recalled?
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0648-2021.