Events

Recall of ROYAL FLUSH PLUS NYLON CATHETER WITH BEACON TIP

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

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
    31887
  • Event Risk Class
    I
  • Event Initiated Date
    2015-07-07
  • 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
    Catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include loss of device function medical intervention to retrieve separated segment or complications resulting from separated tip occluding blood flow to end organs.

Device

ROYAL FLUSH PLUS NYLON CATHETER WITH BEACON TIP
  • Model / Serial
    Model Catalog: HNR4.0-XXX (Lot serial: >10 see importer); Model Catalog: HNBR5.0-XXX (Lot serial: >10 see importer); Model Catalog: SCBR5.0-XXX (Lot serial: >10 see importer)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    ROYAL FLUSH PLUS NYLON CATHETER WITH BEACON TIP
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.