GE Healthcare Pediatric Defibrillation Electrodes Recalled for Arcing Risk

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

• arcing
• device-malfunction

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.

Distribution

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