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U.S. Department of Health and Human Services

Class 1 Device Recall Skintact Electrodes for Defibrillation

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  Class 1 Device Recall Skintact Electrodes for Defibrillation see related information
Date Initiated by Firm September 01, 2016
Date Posted October 14, 2016
Recall Status1 Terminated 3 on March 26, 2019
Recall Number Z-0004-2017
Recall Event ID 75181
510(K)Number K142803  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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.
Code Information US: 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-0771; 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.
Recalling Firm/
Manufacturer		 Leonhard Lang Medizintechnik GmbH
Archenweg 56
Innsbruck Austria
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 11,110 ( US 8,040; OUS 3,070)
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.
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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