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

• Reason
• Affected products

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