Events

Recall of ISOTHERMAL CUSTOM INFANT RESPIRATORY BREATHING CIRCUIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    22888
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-11
  • 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
    The carefusion airlife heated infant breathing circuit is being recalled due to a regulatory compliance risk involving a material change. the changes to the gas pathway material may potentially impact the safety of the device and quality of the gas condensates to the patient.

Device

ISOTHERMAL CUSTOM INFANT RESPIRATORY BREATHING CIRCUIT
  • Model / Serial
    Model Catalog: 10127-4H1 (Lot serial: ALL LOTS); Model Catalog: 1208-4H1 (Lot serial: ALL LOTS); Model Catalog: RC51-12002 (Lot serial: ALL LOTS); Model Catalog: 9054-4S2 (Lot serial: ALL LOTS); Model Catalog: RT4851-00 (Lot serial: ALL LOTS); Model Catalog: RT4851-18 (Lot serial: ALL LOTS)
  • Product Description
    ISOTHERMAL CUSTOM INFANT RESPIRATORY BREATHING CIRCUIT
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC