FDAFDA · Alimentos y medicamentos·N.º oficial Z-2305-2017
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
Publicado el 14 de junio de 2017 · Inicio del retiro: 20 de marzo de 2017
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
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Arrow International Inc
- Distribuidor
- Nationwide Distribution
- Lote
- Material number ASK-46702-AH
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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