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Overview

Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action – Incorrect Artwork on Packaging

Recall Information

Recall#
RA-65174 (Health Canada)
FDA Posted 11/06/2017

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 (Ludlow Corp.). The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging.
Hazard: If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
The defibrillation electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected.

For more information, please visit:

Health Canada (HC):
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/65174r-eng.php?_ga=2.34169830.610442264.1520535453-231703729.1490815578

FDA: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm583874.htm

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