GA HEALTH COMPANY LIMITED recalls Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Produ…
- Recall date
- November 3, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0644-2021
- FDA classification
- Class II
- Brand / firm
- GA HEALTH COMPANY LIMITED
- Sold / distributed
- US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Why it was recalled
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
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