CLASS I Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
GE Healthcare Pediatric Direct-Wired Disposable recalled
Leonhard Lang is recalling GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes, distributed nationwide in the US. The recall was initiated on 3 Dec 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0802-2015
- FDA event ID
- 69930
- Recalling firm
- Leonhard Lang, Innsbruck
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Dec 2014
- FDA classified
- 19 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 3 Dec 2014 | Recall initiated by company | |
| 19 Dec 2014 | Classified by FDA | +16 days |
| 31 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: 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.
Where it was distributed
US Nationwide Distribution in the states of OH and TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
Where was it sold?
US Nationwide Distribution in the states of OH and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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