Reported Mar 18, 2026 · Ongoing
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code:…
Physio-Control, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physio-Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003
Is this the product you have?
- PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator
- Electrodes Catalog Numbers11101-000016
- UDI-DI code00721902629013
- Catalog Number11101-000017
- UDI-DI code00721902682483 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 41. 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)
- Lot codes and dates
- Catalog Numbers11101-000016
- UDI-DI code00721902629013
- Catalog Number11101-000017
- UDI-DI code00721902682483
- Lot Numbers
315303315639315858316007320529318931
- Amount recalled
- 16,499 electrodes (US/OUS: 8327/8172)
Where it was sold
Why it was recalled
Due to pediatric defibrillator electrode delamination
This product could cause temporary or reversible health problems — stop using it.
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