Recalls notice: Infant/child reduced energy defibrillation electrodes
April 24, 2019
Stryker (Physio-Control) is voluntarily recalling specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health. Approximately 14,200 electrodes have been affected.
The defibrillation electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AEDs with a pink connector. There have been no customer complaints reported for this issue.
The artwork on the defibrillation electrodes, as manufactured by Cardinal Health, does not meet Stryker’s specifications, and 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. The artwork on the electrode packaging shows the correct electrode placement for an infant.
If the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. This may result in failure to defibrillate and serious injury or death.
Please check if you have any of the affected lot numbers of the electrodes ref 11101-000016 which are listed on page 2 of the ‘Customer Notification UK PDF’ document. If you find you have some of the affected lot numbers, please isolate them and alert the procurement team of which lot numbers you have and how many so that arrangements for replacements can be made.