GA HEALTH COMPANY LIMITED: Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

Is my product affected?

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

• UPC 04897106950263
• UPC 14897106950260
• UPC 24897106950267

Check against the official notice below — it lists the full affected range.

What happened

GA Health Company Limited has recalled 93,700 units of Andorate Disposable Endoscope Valves Sets nationwide, including distribution in Illinois, New York, New Jersey, Wisconsin, and Minnesota. The recalled product contains suction, air/water, and biopsy valves along with an auxiliary water connector (Product Code: GAR046). The recall was initiated because the suction button may become sticky and/or broken during or after endoscope procedures, which could cause procedures to be prolonged.

The affected lot numbers are 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, and 20061806. The recall notice does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Details from the source

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. Quantity: 93,700 units Lot/code info: Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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