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
Recall
- Recall Number
- Z-3109-2017
- Event Number
- 77949
- Firm
- Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria
- FEI Number
- 6736
- Product Code
- MKJ
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- August 8, 2017
- Posted
- September 12, 2017
- Terminated
- June 9, 2020
Description
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
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.
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.
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.
8,249 units total