Events

Recall of Skintact Electrodes for Defibrillation

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
    75181
  • Event Risk Class
    Class 1
  • Event Number
    Z-0004-2017
  • Event Initiated Date
    2016-09-01
  • 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=149595
  • 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
    There is a risk that defibrillation electrodes model df29n will be connected with the defibrillator welch allyn aed 10 only with delay or not at all. 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
    Consignees was sent via e-mail a Leonhard Lang "Important Safety Notice" dated September 1, 2016. The letter described the product being recalled, Description of the defect, Actions and time frame of the recall, & Compensation for the recalled electrodes. Advised consignees to inform all users within their organizations of the recall; and, secure and destroy the unused electrodes in their inventory. Confirmation of destruction can be done by completing and returning the "Confirmation of Destruction / Consumption" form by October 14, 2016. If the product was further distributed, they were to forward a copy of the Safety Notice. For questions contact sales staff.

Device

Skintact Electrodes for Defibrillation
  • Model / Serial
    US: 60602-0774; 60502-0779; 60308-077; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-077; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.
  • Product Description
    Skintact Electrodes for Defibrillation, DF29N. || Product Usage: || Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
  • Manufacturer
    Leonhard Lang Medizintechnik GmbH

Manufacturer

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