Physio-control, Inc.: Automated External Defibrillators (non-wearable)
- Recalling firm
- Physio-Control, Inc.
- 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...
- Reason
- Due to pediatric defibrillator electrode delamination
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/eeb04128-03e5-4625-a6b0-910974255543