Reported Jun 17, 2020 · Terminated

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

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?

  • 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 Usageintended 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
Lot codes and dates
  • Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date
Amount recalled
118689

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 27, 2023 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.