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

Is my product affected?

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

• UPC 04897106950225
• UPC 14897106950222
• UPC 24897106950229

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

What happened

GA Health Company Limited has recalled 6,470 units of Andorate Disposable Endoscope Valves Sets nationwide, distributed across Illinois, New York, New Jersey, Wisconsin, and Minnesota. The suction valve component in these kits has been reported to have a sticky and/or broken suction button during or after endoscopic procedures, which may cause procedures to be prolonged. The affected product is identified by Unit UDI 04897106950225 and Box UDI 14897106950222, with lot numbers including 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, and 20032503.

The source document does not specify a remedy or action that affected consumers should take regarding this recall.

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: 6,470 units Lot/code info: Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229

Source

Official record: FDA (Device enforcement) ↗

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

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