Events

Recall of Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes

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
    69930
  • Event Risk Class
    Class 1
  • Event Number
    Z-0802-2015
  • Event Initiated Date
    2014-12-03
  • Event Date Posted
    2014-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131992
  • 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
    The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
  • Action
    The one consignee was sent an Urgent Medical Device Recall letter, dated 12/3/2014. The letter identified affected product, explained the issue, and asked for product to stop being used and distributed, and to return the devices. Questions can be addressed to Bettina Sarlay, Sales Manager, Leonhard Lang, at bettina.sarlay@leonhardlang.at.

Device

Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes
  • Model / Serial
    Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of OH and TX.
  • Product Description
    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . || Product Usage: Usage: || Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
  • 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