Events

Recall of Device Recall Zoll MultiFunction Electrode

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
    48753
  • Event Risk Class
    Class 2
  • Event Number
    Z-2334-2008
  • Event Initiated Date
    2008-06-16
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72061
  • 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
    Electrode, electrodcardiograph, multi-function - Product Code MLN
  • Reason
    Multi-function electrode programmed as a pediatric instead of adult.
  • Action
    Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.

Device

Device Recall Zoll MultiFunction Electrode
  • Model / Serial
    Lot #'s : 2108 & 2208
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA
  • Product Description
    ZOLL OneStep Multi-Function Electrode; Adult Complete || Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
  • Manufacturer
    Bio-Detek, Inc.

Manufacturer

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