Events

Recall of Device Recall Zoll pedi.padz Reduced Energy MultiFunction Electrodes (MFE)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Detek, 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
    60835
  • Event Risk Class
    Class 2
  • Event Number
    Z-1011-2012
  • Event Initiated Date
    2011-12-30
  • Event Date Posted
    2012-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106605
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Extra notes in the data
  • Reason
    Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
  • Action
    Zoll Medical issued Urgent Device Correction notices dated 12/30/11 via UPS/Registered Mail. The letter described the issue and identified the affected product. ZOLL recommended that customers alert their staff of the issue, that the electrodes should be kept away from a fluid environment, to use caution in handling the electrodes if they are subjected to a fluid environment and maintain safe defibrillation practice, and seek a replacement if available. Also customers should contact Zoll 1-800-348-9011 for product replacement. The firm plans to replace the affected lots free of charge.

Device

Device Recall Zoll pedi.padz Reduced Energy MultiFunction Electrodes (MFE)
  • Model / Serial
    Lot Numbers 0510 thru 4511
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) || Part number: 8900-0401 || Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients.
  • Manufacturer
    Bio-Detek, Inc.

Manufacturer

Bio-Detek, Inc.
  • Manufacturer Address
    Bio-Detek, Inc., 525 Narragansett Park Dr, Pawtucket RI 02861-4323
  • Source
    USFDA