FDA DeviceClass IINotable

FDA Recall: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016

Date: 2026-03-18
Brand: Physio-Control, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to pediatric defibrillator electrode delamination

Hazard

Due to pediatric defibrillator electrode delamination

Remedy

16,499 electrodes (US/OUS: 8327/8172)

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