Events

Recall of Skintact Multifunction Electrodes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leonhard Lang Medizintechnik GmbH.

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
    77949
  • Event Risk Class
    Class 1
  • Event Number
    Z-3109-2017
  • Event Initiated Date
    2017-08-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158310
  • 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
    Certain lots of the defibrillation electrodes model df59n and df59nc may have a delay in connecting or not connect at all with the defibrillator zoll aed plus. this may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
  • Action
    On approximately 08/08/2017, customers were notified via email of the recall. Instructions included to ensure all users and anyone concerned are aware of the recall, coordinate the replacement of affected product, once replacement electrodes are received document destruction of affected product on-site, and notify customers if the product had been further distributed.

Device

Skintact Multifunction Electrodes
  • Model / Serial
    Model Number DF59N (lot numbers 41219-0778, 50403-0772, 41029-0770), DF59NC (lot numbers 50211-0974, 50402-0974, 40806-0972, 41203-0973, 50116-0975, 50527-0974). Expiration date 09/2017 to 05/31/2018.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom.
  • Product Description
    Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. || Product Usage: || Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. || Used with automated external defibrillators
  • Manufacturer
    Leonhard Lang Medizintechnik GmbH

Manufacturer

Leonhard Lang Medizintechnik GmbH
  • Manufacturer Address
    Leonhard Lang Medizintechnik GmbH, Archenweg 56, Innsbruck Austria
  • Source
    USFDA