Volver al buscador
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

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta