October 18, 2016

FDA: Class I recall of Skintact DF29N Multi-function Defibrillation Electrodes

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on October 14 categorized the recall by Leonhard Lang of its Skintact DF29N Multi-function Defibrillation Electrodes as Class I, the most serious.

The electrode is being recalled because of a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED), model 10.

The user may not be able to connect the electrodes to the defibrillator when a shock is needed, which may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.

 

FDA3Posted 10/14/2016] AUDIENCE: Risk Manager, Emergency Medicine, Patient ISSUE: 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.

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