FDAFDA · Food and drugs·Recall number Z-0641-2021
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Published December 30, 2020 · Recall initiated: November 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Distributor
- US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
- Lot
- Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Hong Kong SAR
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