US FDA issues Class I recall for 8040 Leonhard Lang multifunction defibrillation electrodes

Leonhard Lang multifunction defibrillation electrodes
Leonhard Lang multifunction defibrillation electrodes

The Leonhard Lang defibrillation electrode DF29N is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The FDA has identified this as a Class I recall, “the most serious type of recall”. Use of these devices “may cause serious injuries or death”.

The product in question is also known as the 50028 Defibrillation Electrode SKINTACT DF29N. Lot numbers affected are as follows:

60602-0774, 60502-0779, 60308-0771,60114-0773, 51023-0775, 50904-0777, 50403-0778, 50130-0777, 41023-0771, 41008-0778 40730-0778, 40618-0778, 40130-0776

These lots will have been distributed between February 14, 2014, and August 3, 2016. The total number of products being recalled is 8040.

Figure: 50028 Defibrillation Electrode SKINTACT DF29N

According to the recall notice, “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”.

The FDA notice concludes, “A delay in therapy could result in serious patient injury and/or death.”