STOPCON Disposable Valves Set-Single Use Valves recall
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
Why was STOPCON Disposable Valves Set-Single Use Valves recalled?
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103
- 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
- Recalling firm
- GA HEALTH COMPANY LIMITED
- Quantity
- 25,000 units
- Distribution
- US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)