Physio-Control Inc., is recalling certain infant/child defibrillator electrodes because the artwork on the pads within the packaging shows the incorrect placement instructions for infants. Placing the electrodes on an infant incorrectly could fail to deliver an effective shock to an infant in cardiac arrest, which could result in serious injury or death. A total of 7.973 units distributed nationwide are affected by this recall.
Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The primary users of AEDs are first responders and hospital health care providers.
The recall affects the electrodes used on the LIFEPAK EXPRESS® AED, LIFEPAK CR® Plus AED, LIFEPAK® 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Affected electrodes have the model/item numbers 11101-000016 and 11101-000017, and the lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012. They were distributed nationwide from May 30, 2017 to Aug. 10, 2017.
In October, Physio-Control Inc., issued a Voluntary Field Action to provide customers with the correct electrode placement instructions to be included with the AEDs until they receive their correct defibrillator electrodes.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice