GA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect
GA Health Company Limited is recalling 10,000 ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect in a medical device that may prolong procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GA Health Company Limited is recalling 10,000 units of the ScopeValet Guardian Disposable Endoscope Valves Set (Product Code: 345SVVO4). The recall affects the Air/Water, Suction, Biopsy Valve, and Auxiliary Water Connector components. The product was distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
The recall was initiated because the suction button on the device is reported to be sticky and/or broken during or after the procedure. This defect may cause the medical procedure to be prolonged. The specific lot number for the affected units is 19122419. Unit UDIs are 0810929043732, Box UDIs are 10810929043739, and Carton Box UDIs are 20810929041640.
Healthcare facilities and consumers who have this product should stop using it and contact GA Health Company Limited for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 10,000
Distribution
Part of a larger recall action
This product is one of 11 recalled by GA HEALTH COMPANY LIMITED under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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