FDA Medical Device Recalls (openFDA)
Leonhard Lang Gmbh: 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.
- Recall number
- Z-0802-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-12-03
- Posted
- 2014-12-19
- Terminated
- 2015-08-13
- 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.
- 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 bettina.sarlay@leonhardlang.at.
- Quantity
- 1080 pieces
- Distribution
- US Nationwide Distribution in the states of OH and TX.
- Lot, serial or model codes
- Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
- 510(k) numbers
- ["K081371"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 6736
- Firm city
- Innsbruck
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28