Events

Safety Alert for Compact Suction Unit

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

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
    2015-04-27
  • Event Date Posted
    2015-04-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150427b.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: laerdal compact suction unit medical device manufacturer, laerdal, has issued a medical device safety alert concerning its laerdal compact suction unit [model number: 88005103 and 88006103; serial numbers: 150303a0479 to 150303a0493]. a limited number of laerdal compact suction unit 4 units placed on the market have been manufactured with a material that does not meet its specification. all affected units have passed the functional test performed before release and are capable of achieving maximum vacuum. however, lifetime and performance at operating temperature limits (high/ low temperatures) is unknown. therefore, the units with serial numbers listed above must be returned to the manufacturer. units with affected serial numbers must be removed from use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 april 2015.

Device

Compact Suction Unit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Laerdal Compact Suction Unit
  • Manufacturer
    Laerdal

Manufacturer

Laerdal