FDAFDA · Alimentos y medicamentos·N.º oficial Z-2279-2017
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). The ARROWg+ard Blue PLUS¿ Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSI's compared to the original ARROWg+ard Blue¿ catheter has not been studied
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 CDA-42703-P1A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States