Events

Safety Alert for Neptune 2 Ultra Waste Management System

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

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
    2013-12-24
  • Event Date Posted
    2013-12-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224b.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: stryker neptune 2 ultra waste management system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning neptune 2 ultra waste management system, manufactured by stryker. details of affected products are as follows: catalogue no.: 0702-001-000, 0702-002-000, 0700-001-000, 0700-002-000, 0700-003-000, 0700-007-000 lot no.: all the manufacturer has received four serious complaints where it was determined that the neptune rover had been connected to a passive chest drainage tube post-operatively resulting in patient haemorrhage. furthermore, the manufacturer advises users of the followings: quarantine the affected products until stryker is able to provide upgrades to units. ensure that the above mentioned devices are not used and alternative methods of suction should be sought. quarantined devices are recommended to undergo decontamination by a stryker field service representative to ensure there is no standing water or fluid left in the devices while they are in quarantine. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

Neptune 2 Ultra Waste Management System

Manufacturer

Stryker
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH