FDA recall Z-0648-2021

GA HEALTH COMPANY LIMITED · Class II · device

Product

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-11-03
Report date
2020-12-30
Termination date
2021-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shatin N.T., N/A, Hong Kong SAR

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2021