Recall Z-0802-2015 ยท MKJ Automated External Defibrillators (Non-Wearable)
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 on
| Date | Dec 19, 2014 (initiated Dec 3, 2014) |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL Leonhard Lang GmbH, Sep 24, 2008 |