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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
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35831

Recalled Products

Gas/Water Feeding Valve - OF-B194

Reason

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
Companies
Manufacturer
Hoya Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku,
Tokyo, Tokyo-to
161-8525
JAPAN