| Class 1 Device Recall Skintact Multifunction Electrodes | |
Date Initiated by Firm | August 08, 2017 |
Date Posted | September 12, 2017 |
Recall Status1 |
Terminated 3 on June 09, 2020 |
Recall Number | Z-3109-2017 |
Recall Event ID |
77949 |
510(K)Number | K142803 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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