Class I — Leonhard Lang Gmbh
| Recalling firm | LEONHARD LANG GMBH |
|---|---|
| Registered facility | LEONHARD LANG GMBH (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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 (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. |
| Quantity | 1080 pieces |
| Distribution | US Nationwide Distribution in the states of OH and TX. |
| Initiated | 2014-12-03 |
| Classified | 2014-12-19 |
| Terminated | 2015-08-13 |
| Recall number | Z-0802-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Leonhard Lang Gmbh (Z-0802-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69930/
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