Recall Z-1544-2026— Physio-Control, Inc.
Class II · Ongoing
Class II FDA medical device recall by Physio-Control, Inc., initiated 2026-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).. Reason: Due to pediatric defibrillator electrode delamination.
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-21
- Firm location
- Redmond, WA, United States
Product description
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
Reason for recall
Due to pediatric defibrillator electrode delamination
Data sourced from openFDA. This site is unofficial and independent of the FDA.