Physio-Control recalled 16,499 Infant/Child Reduced Energy Defibrillator Electrodes after reports of delamination. This defect can significantly reduce the effectiveness of the defibrillation. Healthcare providers and patients must stop using the electrodes immediately and follow the recall instructions.
Due to pediatric defibrillator electrode delamination
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Physio-Control, Inc. or your healthcare provider for instructions. Notification method: Letter
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Infant/Child Reduced Energy Defibrillator Electrodes are designed for safely delivering defibrillation to young patients using AED devices. They are essential in emergency medical situations for infants and children under 8 years old or under 25 kg.
The hazard arises from potential delamination of the electrode layers, which may lead to ineffective shocks in critical situations. This problem can prevent the electrodes from adhering properly and delivering the needed energy.
This recall is not part of a broader industry pattern.
The recall affects 16,499 electrodes, which may leave users without an effective treatment option in emergencies. Healthcare providers and caregivers must replace recalled electrodes promptly to ensure patient safety.
The catalog and lot numbers are typically found on the packaging of the electrodes or on the device itself where they are attached.
Refund or replacement processing typically takes 4 to 6 weeks after submission for the recall.
Keep records of all correspondence with the manufacturer, including emails, receipts, and photographs of the product.
Catalog Numbers: 11101-000016, 11101-000017 UDI-DI codes: 00721902629013, 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931 Sold worldwide, including U.S. states AK, AL, AZ, and others.
No injuries or incidents have been reported.
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