GA Health STOPCON Disposable Valves Recalled for Sticky or Broken Suction Buttons
GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves Set-Single Use. The product is distributed by Key Surgical in Eden Prairie, Minnesota, and was distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, and Michigan.
The recall was initiated because the suction button on the valves is reported to be sticky and/or broken during or after the procedure. This defect may cause the procedure to be prolonged. The affected lot numbers are 19121830 and 20031604.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected valves. The FDA has classified this as a Class II recall.
The recalled product
- Product
- STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Category
- Medical Device — Surgical Valves
- Affected units
- 25,000
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: 19121830
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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- HighGA Health Company Recalls STOPCON Disposable Valves Due to Defects
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