Arrow International Inc recalls 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen…

Recall date

May 9, 2017

Source

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

Recall number

Z-2333-2017

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

1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins