Events

Recall of BLENDOX AII5000F INHALATION ANTALGIC SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMBULANC (SHENZHEN) TECH. CO. LTD..

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
    57163
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-02
  • 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
    Ambulanc received one hospital report of oxygen backflow through a device into the nitrous oxide source line which caused gas line contamination. no injury or potential hazard to patients resulted through the incident. company's investigation has identified the root cause and corrective and preventative actions have been determined. although there are no evidence suggesting the same problem will occur with the other units sold in canada company is initiating this action as a precautionary measure.

Device

BLENDOX AII5000F INHALATION ANTALGIC SYSTEM
  • Model / Serial
    Model Catalog: C10090 (Lot serial: AII5000F00611E-AII5000F00642E); Model Catalog: C10090 (Lot serial: AII5000F00651E-AII5000F00731E)
  • Product Description
    BLENDOX AII5000F-INHALATION ANTALGIC SYSTEM
  • Manufacturer
    AMBULANC (SHENZHEN) TECH. CO. LTD.

Manufacturer

AMBULANC (SHENZHEN) TECH. CO. LTD.