Events

Recall of PNEUMO SURE HIGH FLOW INSUFFLATOR - HEATED TUBESET WITH RTP

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
    100049
  • Event Risk Class
    III
  • Event Initiated Date
    2010-02-10
  • 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
    Stryker endoscopy has become aware that the pneumo sure heated tube set has the potential to display an error message stating "check/change tube set" and then the flow drops to a maximum of 11 liters/minute. if the issue is not resolved pneumoperitoneum may take longer to establish due to the limited flow.

Device

PNEUMO SURE HIGH FLOW INSUFFLATOR - HEATED TUBESET WITH RTP
  • Model / Serial
    Model Catalog: 0620-040-690 (Lot serial: 003809W); Model Catalog: 0620-040-690 (Lot serial: 003109W); Model Catalog: 0620-040-690 (Lot serial: 011709W); Model Catalog: 0620-040-690 (Lot serial: 010509W); Model Catalog: 0620-040-690 (Lot serial: 011909W); Model Catalog: 0620-040-690 (Lot serial: 089608W); Model Catalog: 0620-040-690 (Lot serial: 003609W); Model Catalog: 0620-040-690 (Lot serial: 095009W); Model Catalog: 0620-040-690 (Lot serial: 011609W); Model Catalog: 0620-040-690 (Lot serial: 102008W)
  • Product Description
    PNEUMO SURE HEATED TUBE SET
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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