FDA-Device2026-03-18Class IIPACKAGING DEFECT
Physio-Control infant/child defibrillator electrodes recalled for delamination risk
OTHERNationwide distribution
Stop using Physio-Control pediatric defibrillator electrodes
Physio-Control infant and child defibrillator electrodes may separate or peel apart during use, which could prevent proper delivery of therapy. The affected electrodes are pre-gelled, self-adhesive pads designed for use with automated external defibrillators (AEDs) on children under 8 years old or weighing less than 55 pounds. No injuries have been reported.
- Check your AED equipment for the affected catalog numbers: 11101-000016 or 11101-000017
- If you have these electrodes, stop using them immediately and remove them from your AED
- Contact Physio-Control or your AED supplier for replacement electrodes
- Verify your replacement electrodes are from an unaffected lot number
Hazard
Due to pediatric defibrillator electrode delamination
Sold states
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.
Affected count
16,499 electrodes (US/OUS: 8327/8172)
Manufactured in
11811 Willows Rd Ne, N/A, Redmond, WA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2026Don't want to check this manually?
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