GA Health Company Recalls STOPCON Disposable Valves Due to Defects
GA Health Company is recalling 12,800 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging medical 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 risk-of-harm product (prolonged procedure) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
GA Health Company Limited is recalling 12,800 units of STOPCON Disposable Valves Set-Single Use (Product Code: EN10229). The affected lots are 19121831 and 20032007. These medical devices were 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 valves is reported to be sticky and/or broken during or after a procedure. This defect may cause the medical procedure to be prolonged. The agency has classified this recall as Class II.
Healthcare facilities and consumers should check their inventory for the specific lot numbers and UDIs listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor, Key Surgical, or the manufacturer, GA Health Company Limited, for further instructions.
The recalled product
- Product
- STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 12,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 19121831
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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