FDA Warns of Class I Recall of Leonhard Lang External Defibrillator Electrode Due to Incompatibility Issue

Larry Hand

Disclosures

October 14, 2016

SILVER SPRING, MD — The Food and Drug Administration has issued a class I recall on the Leonhard Lang defibrillation electrode due to connector incompatibility with the Welch Allyn AED Model 10 defibrillator[1].

The specific product is the 50028 Defibrillation Electrode Skintact DF29N. Lot numbers are:

  • 60602-0774.

  • 60502-0779.

  • 60302-0771.

  • 60114–0773.

  • 51023-0775.

  • 50904-0777.

  • 50403-0778.

  • 50103-0777.

  • 41023-0771.

  • 41008-0778.

  • 40730-0778.

  • 40618-0778..

Distribution dates were between February 14, 2014 and August 3, 2016.

Leonhard Lang sent a safety alert to customers on September 1 asking them to make sure all DF29N electrodes are destroyed and confirm that with the supplier.

Healthcare professionals who have questions can contact MedWatch, the FDA's safety information and adverse-event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online; with postage-paid FDA form 3500, available online; or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

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