Events

Safety Alert for Medasil Airway (Guedel type)

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

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
    2015-12-15
  • Event Date Posted
    2015-12-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151215.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: medasil airway (guedel type) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning medasil airway (guedel type), code 38/2 size 2, manufactured by medasil surgical. the affected product identifiers are lot wh61, consignments 355 and 363, expiry 2019/03. the problem relates to a single device returned to the manufacturer by a user, in which the distal end of the airway was completely blocked. this fault represents a potential serious hazard to patient safety (i.E. suffocation) if the fault is not identified before use in patients. the manufacturer is performing an immediate recall of the affected lot of airway products. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-7-to-11-december-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 december 2015.

Device

Medasil Airway (Guedel type)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medasil Airway (Guedel type)
  • Manufacturer
    Medasil Surgical

Manufacturer

Medasil Surgical