Events

Recall of PEDI-PADZ SOLID GEL MULTI-FUNCTION 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
    138958
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-27
  • 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
    Through our post-market surveillance program we have identified that a small quantity of the zoll pedi-padz solid gel multi-function electrodes (part numbers 8900-3000-01 and 8900-3001-01) manufactured in april 2015 (lot number 1615) have been labelled with the wrong expiration date and part number.

Device

PEDI-PADZ SOLID GEL MULTI-FUNCTION ELECTRODE
  • Model / Serial
    Model Catalog: 8900-3000-01 (Lot serial: 1615); Model Catalog: 8900-3001-01 (Lot serial: 1615)
  • Product Description
    PEDI-PADZ SOLID GEL MULTI-FUNCTION ELECTRODES
  • Manufacturer
    ZOLL MEDICAL CANADA INC.

Manufacturer

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