Events

Safety Alert for Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cardinal Health.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-08
  • Event Date Posted
    2013-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cardinal health various presource kits containing a pre-assembled anesthesia circuit the united states food and drug administration (fda) has issued a medical device safety alert, concerning various presource kits containing a pre-assembled anesthesia circuit, manufactured by cardinal health. cardinal health discovered that various presource kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. if the packaging is removed without dissembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. this may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation and death. according to the fda, cardinal health has notified customers of the problem and products affected on 26 march 2013 and advised customers to examine their inventories, identify and locate the products affected, notify clinicians, and affix a warning label on the front of each kit. the warning label instructs clinicians to remove and discard the anesthesia circuit and filter assembly. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safety alertsforhumanmedicalproducts/ucm351024.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm350996.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cardinal Health Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health