Arrow International Inc recalls Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety…

Recall date

May 9, 2017

Source

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

Recall number

Z-2332-2017

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Worldwide Distribution - US (nationwide) and Canada

Why it was recalled

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

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

What was recalled

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days