Reported Dec 30, 2020 · Terminated
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL…
Ga Health Company Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GA HEALTH COMPANY LIMITED · Unit 18, 21/F · Shatin N.T., N/A · N/A
Is this the product you have?
- STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus
- R (Air-Water-/Suction) DISTRIBUTED BYKEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE
- MN 55344 / USA Product CodeEN10229.2
- Lot codes and dates
- Lot Numbers19121829
- Unit UDI04897106951116
- Box UDI14897106951113
- Cartoon Box UDI24897106951110
- Amount recalled
- 11,000 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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