Events

Safety Alert for 22mm Flextube Transport Breathing Systems with non-rebreathing valve

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

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
    2017-08-22
  • Event Date Posted
    2017-08-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170822.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: intersurgical 22mm flextube transport breathing systems with non-rebreathing valve the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning 22mm flextube transport breathing systems with non-rebreathing valve, manufactured by intersurgical limited. [ref numbers: 2070000, 2070001, 2073000, 2074000, 2075000 and 5020002; lot numbers: from 31258704 to 31755743] the manufacturer has voluntarily initiated a global recall of specific product codes and associated lots above of the 22mm flextube transport breathing systems with nonrebreathing valve. a fault has been identified in a non-rebreathing valve component in the affected products, and could result in an occlusion due to the valve sticking. if a ventilator with no self test facility is being used the fault may not be identified. the outcome for the patient will depend on a number of variables, including the degree of occlusion and how quickly the source of the problem is identified allowing remedial action to be taken. according to the manufacturer, an internal assessment of product performance has confirmed that these devices can potentially raise serious risk to the patient. for this reason and to address any potential risk of harm, the affected products should not be used and should be destroyed. the affected users are advised to stop the use of all affected devices immediately and ensure they are quarantined and destroyed. the manufacturer is working to resolve this situation and in the meantime they have an alternative replacement for the systems that do not have an adjustable peep valve or monitoring line (alternative product code 2080004). for details, please refer to the following link: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-14-to-18-august-2017 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 august 2017.

Device

22mm Flextube Transport Breathing Systems with non-rebreathing valve
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Intersurgical 22mm Flextube Transport Breathing Systems with non-rebreathing valve
  • Manufacturer
    Intersurgical Limited

Manufacturer

Intersurgical Limited