Reported Dec 31, 2014 · Terminated

GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .…

Leonhard Lang GmbH

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Leonhard Lang Gmbh · Archenweg 56 · Innsbruck · N/A

Is this the product you have?

  • GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005
  • Product UsageUsage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only
Lot codes and dates
  • Lots
    • 30618-0771
    • 30702-0778
    • 40217-0776
    • 40407-0777
    • 40424-0772
    • 40704-0775
Amount recalled
1080 pieces

Where it was sold

Why it was recalled

Stop using this product now

The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 13, 2015 · Data as of Sep 19, 5:20 PM UTC

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