FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes

Editor's Note

The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio).

There is an issue with the artwork on the electrodes that shows incorrect electrode placement for an infant. Incorrect placement of the defibrillation electrodes may result in ineffective energy delivery to the patient and serious injury or death.

The company is providing customers with correct electrode placement instructions to be included with their automated external defibrillators until they receive the corrected electrodes. 

Electrodes used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector [Posted 11/06/2017] AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Physio-Control announced it is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health.

Read More >>