PlainRecalls
FDA Devices Moderate Class II Terminated

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

Reported: December 30, 2020 Initiated: November 3, 2020 #Z-0643-2021

Product Description

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

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
6,470 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?
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004. Recalled by GA HEALTH COMPANY LIMITED. Units affected: 6,470 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-0643-2021.