Events

Recall of PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT

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

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
    79806
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-08
  • 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
    When operating the device in high flow mode (40l/min 15 mmhg) and connecting to a house gas inlet source within seconds of insufflating the flow rate would drop to 0l/min and the red "check gas supply" symbol would appear on the display immediately suspending insufflation.

Device

PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT
  • Model / Serial
    Model Catalog: 620-040-610 (Lot serial: 1101CE178)
  • Product Description
    PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC