FDA recently issued a Class I designation for Leonhard Lang’s recall of its 50028 defibrillation electrode Skintact DF29N series.
More than 8000 electrodes in the U.S. are involved in the recall, which is taking place because of connector compatibility issues between this device when used with the Welch Allyn AED model 10 defibrillator. The electrodes were distributed between February 14, 2014 and August 3, 2016. More information is available on FDA’s website.