FDAFDA · Food and drugs·Recall number Z-2290-2014
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Published August 27, 2014 · Recall initiated: July 17, 2014
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
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax Medical Company
- Distributor
- Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
- Lot
- Model No. OF-B130 OF-B194, all units.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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