Arrow International Inc recalls Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to centr…

Recall date

March 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1879-2017

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US Distribution to NJ, IL, and PA

Why it was recalled

Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. 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 ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied