Events

Recall of ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

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
    34565
  • Event Risk Class
    I
  • Event Initiated Date
    2016-06-22
  • 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
    Cook medical is initiating a voluntary recall because of a potential coating contamination. dsm biomedical b.V. the netherlands our supplier of the coating has recalled some of its coating material because of concerns about potential component contamination with glass particles. the reported glass particle size ranged from approximately 4 to 280 micro meter.

Device

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
  • Model / Serial
    Model Catalog: HPWA-35-180 (Lot serial: 6955231); Model Catalog: HPW-35-150 (Lot serial: 6955231); Model Catalog: HPWAS-35-180 (Lot serial: 6955229); Model Catalog: HPW-35-150 (Lot serial: 6955229); Model Catalog: HPWA-35-180 (Lot serial: 6955229); Model Catalog: HPWAS-35-180 (Lot serial: 6955228); Model Catalog: HPW-35-150 (Lot serial: 6955228); Model Catalog: HPWA-35-180 (Lot serial: 6955228); Model Catalog: HPWAS-35-180 (Lot serial: 6911527); Model Catalog: HPW-35-150 (Lot serial: 6911527); Model Catalog: HPWA-35-180 (Lot serial: 6911527); Model Catalog: HPWAS-35-180 (Lot serial: 6911524); Model Catalog: HPW-35-150 (Lot serial: 6911524); Model Catalog: HPWA-35-180 (Lot serial: 6911524); Model Catalog: HPWAS-35-180 (Lot serial: 6911535); Model Catalog: HPW-35-150 (Lot serial: 6911535); Model Catalog: HPWA-35-180 (Lot serial: 6911535); Model Catalog: HPWAS-35-180 (Lot serial: 7015855); Model Catalog: HPW-35-150 (Lot serial: 7015855); Model Catalog: HPWA-35-180 (Lot serial: 7015855); Model Catalog: HPWAS-35-
  • Product Classification
    Cardiovascular Devices
  • Product Description
    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.