Physio-Control, Inc. is recalling 16,499 Infant/Child Reduced Energy Defibrillator Electrodes due to a defect where the electrode gel may peel away (delamination). These self-adhesive therapy electrodes are designed to reduce the energy delivered to infants and children under 8 years old or weighing less than 55 lbs during emergency defibrillation. The recall affects specific lots distributed worldwide and nationwide across the United States. If you have these electrodes, you should contact the manufacturer or your distributor to arrange for a replacement or correction.
The electrode gel can peel away from the pad, which may prevent the device from delivering the necessary electrical therapy during a life-threatening cardiac event. This failure to deliver a shock could result in serious injury or death for a pediatric patient.
Therapy electrodes that reduce energy delivered by a 4:1 factor for infants and children under 8 years old or 25kg (55lbs).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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