Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0802-2015 — 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 externa

U.S. FDA — Device Enforcement · Austria · 2014-12-03 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0802-2015
Date of alert: 2014-12-03
Country / jurisdiction: Austria
Risk level: Class I
Risk type: recall
Brand: Leonhard Lang Gmbh
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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