FDAFDA · Food and drugs·Recall number Z-0084-2014
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
Published November 6, 2013 · Recall initiated: September 16, 2013
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
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax Medical Company
- Distributor
- Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
- Lot
- Model OF-B194
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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