Events

Safety Alert for Pedi-Padz Reduced Energy Electrode, Model # 8900-0401

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Zoll Medical Corporation.

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
    2012-02-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120209.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
    Field safety notice: zoll pedi-padz reduced energy electrode, model # 8900-0401 health canada, has issued a type ii recall on pedi-padz reduced energy electrode, model # 8900-0401, manufactured by zoll medical corporation. according to the manufacturer, the products are being recalled because a problem was identified through the supplier’s internal quality system on a production lot. the issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation. the affected lot numbers were from 0511 to 4511. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Zoll Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation