Events

Recall of GAS/WATER FEEDING VALVE- OF-B194

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15660
  • Event Risk Class
    I
  • Event Initiated Date
    2013-09-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

GAS/WATER FEEDING VALVE- OF-B194

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC