Events

Recall of ZOLL READY-PADZ ONE-STEP COMPLETE ELECTRODE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZOLL MEDICAL 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
    105618
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-11
  • 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
    A portion (640 out of 3400) of the id chips in the electrodes for lot 2517a were inadvertently programmed as pediatric electrodes instead of adult electrodes.

Device

ZOLL READY-PADZ ONE-STEP COMPLETE ELECTRODE
  • Model / Serial
    Model Catalog: 8900-0214 (Lot serial: 2517A); Model Catalog: (Lot serial: 2517A)
  • Product Description
    ZOLL ONESTEP COMPLETE ELECTRODES (case);ZOLL ONESTEP COMPLETE ELECTRODE
  • Manufacturer
    ZOLL MEDICAL CANADA INC.

Manufacturer

ZOLL MEDICAL CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    HC