FDAFDA · Food and drugs·Recall number Z-0802-2015
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.
Published December 31, 2014 · Recall initiated: December 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leonhard Lang Gmbh
- Distributor
- US Nationwide Distribution in the states of OH and TX.
- Lot
- Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- Austria
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