FDA recall Z-0645-2021

GA HEALTH COMPANY LIMITED · Class II · device

Product

Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

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-0645-2021