Events

Recall of NEPTUNE 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
    25796
  • Event Risk Class
    I
  • Event Initiated Date
    2013-08-26
  • 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
    Stryker has received additional reports of serious injury or death in procedures where the neptune was connected to a passive chest drainage tube or closed wound drainage device post-operatively. as a result of the additional reported adverse events as well as information suggesting that not all users of the neptune devices were trained on the risks associated with using the device stryker is requiring additional actions to be implemented in order for facilities to continue use of their neptune device(s).

Device

NEPTUNE ROVER

Manufacturer

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