Events

Recall of QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHYSIO-CONTROL CANADA SALES 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
    120764
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-04
  • 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
    Physio-control's supplier of quik-combo adult pacing/defibrillation/ecg electrodes with edge system technology and redi-pak preconnect system is voluntarily recalling specific production lots. the defibrillation electrodes are used in conjunction with certain physio-control lifepak products. this voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of the affected lots. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy arcing of current sparking and patient and/or clinician burns.

Device

QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE
  • Model / Serial
    Model Catalog: 3202674-XXX (Lot serial: 516907); Model Catalog: 3202674-XXX (Lot serial: 519815); Model Catalog: 3202674-XXX (Lot serial: 519816)
  • Product Description
    PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM;Quik-Combo pacing/defibrillation/ECG electordes with EDGE System technology and REDI-PAK preconnect system
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC