Events

Recall of HIGH FREQUENCY OSCILLATORY VENTILATOR MODEL 3100B

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

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
    63139
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-13
  • 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
    There have been reports of failures of cap / diaphragm assemblies. specific lots of cap/ diaphragm assemblies used with 3100a or 3100b high frequency oscillatory ventillators could fail thereby preventing the targeted mean airway pressure (39 - 43 cm h20) being reached during system calibration test set up prior to being used on patients.

Device

HIGH FREQUENCY OSCILLATORY VENTILATOR MODEL 3100B
  • Model / Serial
    Model Catalog: 3100B (Lot serial: >10 lot numbers.); Model Catalog: 3100B (Lot serial: Contact manufacturer.); Model Catalog: MODEL 3100A (Lot serial: Contact manufacturer.); Model Catalog: MODEL 3100A (Lot serial: >10 lot numbers.)
  • Product Description
    High Frequency Oscillatory Ventilator Model 3100B (Cap Diaphragm)
  • Manufacturer
    CAREFUSION

Manufacturer

CAREFUSION