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.
The specific product is the 50028 Defibrillation Electrode Skintact DF29N. Lot numbers are:
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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Cite this: FDA Warns of Class I Recall of Leonhard Lang External Defibrillator Electrode Due to Incompatibility Issue - Medscape - Oct 14, 2016.