On October 14, 2016, Leonhard Lang recalled its 50028 Defibrillation Electrode SKINTACT DF29N due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.
Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. A delay in therapy could result in serious patient injury and/or death.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue
See also Medical Law Perspectives, December 2012 Report: When Urgency Leads to Errors: Liability for Emergency Care