Events

Safety Alert for Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Physio-Control Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-02-16
  • Event Date Posted
    2016-02-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160216.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: physio-control adult-edge electrode with quik-combo connector and redi-pak preconnect the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning adult-edge electrode with quik-combo connector and redi-pak preconnect manufactured by physio-control inc. [catalogue number: 11996-000017; min number: 3202674-005; lot numbers: 516907, 519815, 519816]. the manufacturer conducted a voluntary recall of the abovementioned product due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. the defibrillation electrodes used in conjunction with certain physio-control lifepakr products. 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 bum. the manufacturer advises customers to quarantine the affected products and return them to the manufacturer. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 february 2016.

Device

Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Manufacturer
    Physio-Control Inc.

Manufacturer

Physio-Control Inc.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH