FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 31 de diciembre de 2014 · Inicio del retiro: 3 de diciembre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Leonhard Lang Gmbh
- Distribuidor
- US Nationwide Distribution in the states of OH and TX.
- Lote
- Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- Austria
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