FDAFDA · Alimentos y medicamentos·N.º oficial Z-0477-2015
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
Publicado el 3 de diciembre de 2014 · Inicio del retiro: 1 de abril 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
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ZOLL Circulation, Inc.
- Distribuidor
- One location in NC
- Lote
- Model 1027, Catalog number 8700-000775-01, lot 0021.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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