Recall Z-0648-2021— GA HEALTH COMPANY LIMITED
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: ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1. 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 recordK-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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.