Events

Recall of Device Recall Multifunctional electrode/defibrillation electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leonhard Lang 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
    52794
  • Event Risk Class
    Class 2
  • Event Number
    Z-2233-2009
  • Event Initiated Date
    2009-07-10
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84021
  • 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
    Multifunctional electrodes - Product Code MKJ
  • Reason
    A potential risk was identified associated with the connectors of the defibrillation electrodes df20. it was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. in such cases increased force or some wiggling is required to insert the connector fully. a potential risk for patients exist, if (a) such a connector (b).
  • Action
    A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.

Device

Device Recall Multifunctional electrode/defibrillation electrode
  • Model / Serial
    DF20 SKINTACT  Lot #'s 80506-0771, 80527-0776, 80628-0776, 80826-0773, 80911-0773,
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
  • Product Description
    SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. || The device is non-sterile and single use. || For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.
  • Manufacturer
    Leonhard Lang Gmbh

Manufacturer

Leonhard Lang Gmbh
  • Manufacturer Address
    Leonhard Lang Gmbh, Archenweg 56, Innsbruck Austria
  • Manufacturer Parent Company (2017)
    Leonhard Lang Gmbh
  • Source
    USFDA