RecallRadar

FDA Device recall Z-2359-2020

Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defib…

On 2020-06-17 the FDA classified a Class II recall of Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defib… by Physio Control, citing packaging of infant child reduced energy electrodes was not properly sealed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2359-2020
ClassificationClass II
Statusterminated
Initiated2020-04-24
Published2020-06-17
Last updated2026-09-13 11:55 UTC
CompanyPhysio Control
DistributionUS

Product

Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.

Reason

Packaging of infant child reduced energy electrodes was not properly sealed.

Identifiers

code_infoElectrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Other recalls by Physio Control

All Physio Control recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2359-2020%22

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