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U.S. Department of Health and Human Services

Class 1 Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes

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  Class 1 Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes see related information
Date Initiated by Firm December 03, 2014
Date Posted December 19, 2014
Recall Status1 Terminated 3 on August 13, 2015
Recall Number Z-0802-2015
Recall Event ID 69930
510(K)Number K081371  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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.
Code Information Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
Recalling Firm/
Manufacturer		 Leonhard Lang Gmbh
Archenweg 56
Innsbruck Austria
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 1080 pieces
Distribution US Nationwide Distribution in the states of OH and TX.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = LEONHARD LANG GMBH
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