Class I Recall of Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang

PUBLISHED: Oct 14, 2016
Source: Food and Drug Administration

The US Food and Drug Administration (FDA) is informing healthcare professionals that 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.

Recalled product details:

  • 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

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 thanOctober 14, 2016.
  • Keep the signed "Confirmation of Destruction / Consumption" form until their supplier informed them of the termination of this recall.

Read the MedWatch safety alert, including a link to the FDA recall notice, at the link below.

Want to read the full alert and receive alert emails?

Browse Additional Alerts