Events

Recall of PAXMAN NEOPRENE TAIL COVERS AND HOSE SLEEVES

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

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
    15975
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-26
  • 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
    Labelling of the devices are required to meet section 21 section 22 and section 23 of the medical devices regulations.

Device

PAXMAN NEOPRENE TAIL COVERS AND HOSE SLEEVES
  • Model / Serial
    Model Catalog: 500-08-87B (Lot serial: ); Model Catalog: 500-08-87 (Lot serial: ); Model Catalog: 500-08-86A (Lot serial: ); Model Catalog: 500-08-86 (Lot serial: ); Model Catalog: 500-08-92 (Lot serial: ); Model Catalog: 500-08-91 (Lot serial: ); Model Catalog: 100-08-45 (Lot serial: all lots); Model Catalog: 500-08-89 (Lot serial: ); Model Catalog: 500-08-88 (Lot serial: ); Model Catalog: 100-08-49 (Lot serial: all lots); Model Catalog: 100-08-48 (Lot serial: all lots); Model Catalog: 100-08-47 (Lot serial: all lots); Model Catalog: 100-08-46 (Lot serial: all lots); Model Catalog: 500-08-90 (Lot serial: )
  • Product Description
    PAXMAN TAIL COVERS AND HOSE SLEEVES;PAXMAN SCALP CAP COVER;PAXMAN SCALP SILICONE COOLING CAP;paxman tail covers and hose sleeves;paxman scalp silicone cooling cap;paxman scalp cap cover
  • Manufacturer
    COLD COMFORT CANADA LTD.

Manufacturer

COLD COMFORT CANADA LTD.
  • Manufacturer Address
    WINNIPEG
  • Source
    HC