The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0802-2015·Announced 2014-12-31

GE Healthcare Pediatric Defibrillation Electrodes Recalled for Arcing Risk

Leonhard Lang GmbH is recalling GE Healthcare Pediatric Defibrillation Electrodes because arcing may cause malfunction, delaying or preventing life-saving therapy.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Leonhard Lang GmbH is recalling 1,080 units of GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes (REF 2059144-001 and 2059144-005). The affected lots are 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, and 40704-0775. These devices were distributed in Ohio and Texas.

The recall was initiated because the firm discovered that arcing can occur during use, leading to device malfunction. This malfunction could delay or prevent defibrillation therapy for patients in life-threatening situations. The electrodes are intended for pediatric patients under 8 years of age or weighing less than 25 kg (55 lbs) for external defibrillation, pacing, monitoring, and cardioversion.

Healthcare facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. No specific instructions for individual consumers are provided in the source text, as these are professional medical devices.

The recalled product

Product
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…
Manufacturer
Leonhard Lang Gmbh
Category
Medical Device — Defibrillation Electrodes
Hazard
Affected units
1,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lots: 30618-0771
  • 30702-0778
  • 40217-0776
  • 40407-0777
  • 40424-0772
  • 40704-0775

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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