FDAFDA · Alimentos y medicamentos·N.º oficial Z-2260-2017
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
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 NumberASK-22122-MM
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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