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Gas/Water Feeding Valve - OF-B194 (2013-09-13)

Starting date:
September 18, 2013
Posting date:
September 18, 2013
Type of communication:
Medical Device Recall
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Medical Devices
General Public, Healthcare Professionals, Hospitals
Identification number:

Recalled Products

Gas/Water Feeding Valve - OF-B194


PENTAX Upper/Lower G.I. Endoscopes are provided with an Air/Water Valve. As an alternative, the optionally available OF-B194 Gas/Water Feeding Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas (C02) for insufflation. We have been informed about a product issue involving the OF-B194 Gas/Water Feeding Valve. The reported defect may cause improper stoppage of the supply of CO2 gas during an endoscopic procedure with the potential for serious hazard to the patient (i.e. increased risk of perforation due to continuing flow of CO2 gas). PENTAX Medical has discovered a manufacturing assembly failure, which cannot be corrected at the user facility and therefore the OF-B194 Gas/Water Feeding Valve must be removed from use immediately.

Affected products

A. Gas/Water Feeding Valve- OF-B194

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • OF-B194
Hoya Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku,
Tokyo, Tokyo-to