Device evidence

device-recall:cfres:175289

Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). 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 CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

Official recall number

Z-0192-2020

Evidence summary

Product code: FOZ
Recall status: Terminated
Event initiated: July 18, 2019
Root cause: Packaging process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0192-2020