Events

Recall of NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51369
  • Event Risk Class
    I
  • Event Initiated Date
    2014-01-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The purpose of this correction is to upgrade the neptune 2 waste management system to the new approved specifications. previously stryker had received reports that the neptune 2 had been connected directly to a chest tube postoperatively which resulted in fatalities and injuries. the new approved specifications include a change in technology a control mechanism change as well as a modification to the canister vacuum level regulator [from mechanical to electrical]. the neptune 2 has been re-designed to address the hazards and harms outlined in previously recalls.

Device

NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC