Class 1 Recall: Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 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.

Recalled Product:

  • 50028 Defibrillation Electrode SKINTACT DF29N
  • Lot Numbers: 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
  • Distribution Dates: February 14, 2014, to August 3, 2016
  • Devices Recalled in the U.S.: 8040 nationwide

Device Use

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. The primary users of AEDs are first responders and hospital health care providers.

Reason for Recall

The Leonhard Lang defibrillation electrode is being recalled 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.

A delay in therapy could result in serious patient injury and/or death.

Who May be Affected

  • Health care providers and first responders using this defibrillation electrode
  • Patients who may need this defibrillation electrode to restore normal heart rhythm

What to Do

On September 1, 2016, Leonhard Lang sent an "Important Safety Notice" letter to all affected customers. The letter asked customers to:

  • Review the safety notice and ensure appropriate staff is aware of the notice.
  • Make sure all unused defibrillation electrodes DF29N are secured and destroyed.
  • Confirm the products were destroyed by completing the "Confirmation of Destruction / Consumption" form in the notice.
  • Send the "Confirmation of Destruction / Consumption" form to their supplier no later than October 14, 2016.
  • Keep the signed "Confirmation of Destruction / Consumption" form until their supplier informed them of the termination of this recall.

Contact Information

Health care professionals and consumers with questions are instructed to contact the Leonhard Lang sales staff at (800) 903-6199 with any questions related to this recall.

Date Recall Initiated

September 1, 2016  

 

 

The FDA alerts provided by MedWrench are intended to be helpful reminders, but are not to displace the timely alerts provided by the manufacturers of the products or the FDA directly. You should always consult those services prior to making any final decisions as to the timeliness and accuracy of the FDA alerts we distribute. For more visit www.fda.gov.