Events

Recall of Device Recall Medsolutions4U MultiFunction Electrodes

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
    68970
  • Event Risk Class
    Class 2
  • Event Number
    Z-2565-2014
  • Event Initiated Date
    2013-03-12
  • Event Date Posted
    2014-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129156
  • 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
    Medsoultions4u multi-function lifepak electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators.
  • Action
    Bio-Detek issued an Urgent Field Safety Notice to Medsolutions4 U on 3/12/13, informing them of the problem and actions that should be taken to remove the affected products from service.

Device

Device Recall Medsolutions4U MultiFunction Electrodes
  • Model / Serial
    Lot #0413 Expiration Date: 2015-01-26
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in Germany and Slovenia.
  • Product Description
    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring || Part Number: 2033
  • Manufacturer
    Bio-Detek, Inc.

Manufacturer

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