Recall Z-0643-2021— GA HEALTH COMPANY LIMITED

Name: FDA recall Z-0643-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-03

Class II · Terminated

Class II FDA medical device recall by GA HEALTH COMPANY LIMITED, initiated 2020-11-03, terminated 2021-09-03. It names 2 FDA 510(k) clearances: K182998, K181509. Product: Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004. Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure.

Recalling firm: GA HEALTH COMPANY LIMITED
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Terminated: 2021-09-03
Firm location: Shatin N.T., N/A, Hong Kong SAR

510(k) clearances named in this recall

2 on FDA's record

K182998 — Andorate Auxiliary Water ConnectorSmartdata Suzhou Co., Ltd.·cleared 2019-04-17
K181509 — Endorate Valve SetsSmartdata Suzhou Co., Ltd.·cleared 2018-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.