PENTAX Endoscopic Accessories. OF-B194. Made in Japan. recall
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the…
Why was PENTAX Endoscopic Accessories. OF-B194. Made in Japan. recalled?
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 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?
Model OF-B194
- Product
- PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the…
- Recalling firm
- Pentax Medical Company
- Quantity
- 76 units
- Distribution
- Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
- Recall date
- November 6, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)