Recall Z-0802-2015— Leonhard Lang Gmbh

Name: FDA recall Z-0802-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-03

Class I · Terminated

Class I FDA medical device recall by Leonhard Lang Gmbh, initiated 2014-12-03, terminated 2015-08-13. It names one FDA 510(k) clearance: K081371. 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: 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..

Recalling firm: Leonhard Lang Gmbh
Classification: Class I
Status: Terminated
Initiated: 2014-12-03
Terminated: 2015-08-13
Firm location: Innsbruck, Austria

510(k) clearances named in this recall

1 on FDA's record

K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELLeonhard Lang GmbH·cleared 2008-09-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.