Events

Recall of Zoll

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
    69409
  • Event Risk Class
    Class 2
  • Event Number
    Z-0053-2015
  • Event Initiated Date
    2014-09-16
  • Event Date Posted
    2014-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130465
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    Product sterility is not assured.
  • Action
    Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.

Device

Zoll
  • Model / Serial
    Lot Numbers: 1614, 1814
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • Product Description
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. || Part number: 8900-4013 || Product Usage: || These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
  • Manufacturer
    Bio-Detek, Inc.

Manufacturer

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