• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Skintact Multifunction Electrodes

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Skintact Multifunction Electrodes see related information
Date Initiated by Firm August 08, 2017
Create Date September 12, 2017
Recall Status1 Open3, Classified
Recall Number Z-3109-2017
Recall Event ID 77949
510(K)Number K142803  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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
Code Information 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.
Recalling Firm/
Manufacturer
Leonhard Lang Medizintechnik GmbH
Archenweg 56
Innsbruck Austria
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Component design/selection
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.
Quantity in Commerce 8,249 units total
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = Leonhard Lang GmbH
-
-