GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing… — Class I medical device recall Z-0802-2015
Terminated recall by Leonhard Lang Gmbh, reported 2014-12-31, distributed nationwide. The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resu
| Recall number | Z-0802-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leonhard Lang Gmbh, Innsbruck, Austria |
| Recall initiated | 2014-12-03 |
| Classified | 2014-12-19 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,080 units |
| Reason classes | device malfunction |
| Lot numbers | 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775 |
| Model numbers | 2059144-001, 2059144-005 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0802-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.