Z-0802-2015Class I

GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and...

Name: Z-0802-2015 GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and...
Creator: Leonhard Lang Gmbh
Published: 2014-12-03
License: https://open.fda.gov/license/

Leonhard Lang GmbH / initiated 2014-12-03 / Terminated / root cause: design

FDA source

Leonhard Lang Gmbh began a recall of GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric... on 2014-12-03. FDA classified it as Class I and 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0802-2015
Classification: Class I
Status: Terminated
Initiated: 2014-12-03
Posted: 2014-12-19
Terminated: 2015-08-13
Recalling firm: Leonhard Lang GmbH
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: The one consignee was sent an Urgent Medical Device Recall letter, dated 12/3/2014. The letter identified affected product, explained the issue, and asked for product to stop being used and distributed, and to return the devices. Questions can be addressed to Bettina Sarlay, Sales Manager, Leonhard Lang, at [email protected].
Quantity in commerce: 1080 pieces
Distribution: US Nationwide Distribution in the states of OH and TX.
Product codes and lots: Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0802-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0802-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19

Product code MKJ

K081371Class IIISkintact Pediatric Multifunction Electrodes with Dh03 GelLeonhard Lang GmbH / cleared 2008-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)