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
    43709
  • Event Risk Class
    I
  • Event Initiated Date
    2012-05-14
  • 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 stryker neptune waste management system is intended to be used in the operating room pathology surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as to collect smoke generated from electrocautory or laser devices. stryker instruments was made aware was made aware through informal reports from hospital personnel that a death had occurred and possibly related to use of a neptune rover. the root cause of the problem was confirmed not to be caused by a product malfunction or the result of a non-conformance but rather the event resulted due to a use error.

Device

NEPTUNE ROVER
  • Model / Serial
    Model Catalog: 0702-001-000 (Lot serial: ALL); Model Catalog: 0700-007-000 (Lot serial: ALL); Model Catalog: 0700-001-000 (Lot serial: ALL); Model Catalog: 0700-003-000 (Lot serial: ALL)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    IFU FOR NEPTUNE WASTE MANAGEMENT SYSTEM
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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