FDAFDA · Alimentos y medicamentos·N.º oficial Z-0472-2014
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
Publicado el 25 de diciembre de 2013 · Inicio del retiro: 19 de septiembre de 2013
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
GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
- Lote
- product number M1173310 containing lot numbers 12001 through 13031.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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