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
Enforcement
- Recall Number
- Z-3109-2017
- Event ID
- 77949
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Leonhard Lang Medizintechnik GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 20, 2017
- Initiation Date
- August 8, 2017
- Classification Date
- September 12, 2017
- Termination Date
- June 9, 2020
- Address
- Archenweg 56, N/A, Innsbruck, N/A, N/A, Austria
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.
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.
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