Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk
Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text states that failure to follow instructions may cause a 'potential risk to health' but does not report any specific injuries or illnesses. This aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pentax Medical Company is recalling the PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve. The recall involves 98 units in the United States and 1,108 units outside the United States. The affected units are distributed worldwide, including in the US states of California, Colorado, Indiana, Kansas, and Idaho, as well as in Asia, Canada, Europe, and Japan.
The recall is issued because the Instructions for Use (IFU) for these valves, if not followed carefully, may cause a potential risk to health. The source text does not specify the exact nature of the health risk or report any specific injuries or illnesses.
Healthcare providers and consumers should stop using the affected valves and contact Pentax Medical Company for further instructions on how to proceed.
The recalled product
- Product
- PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- Manufacturer
- Pentax Medical Company
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. OF-B130 OF-B194
- all units.
Distribution
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