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

Recalled June 21, 2017 · FDA recall Z-2333-2017 · Arrow International

Hazard

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

Units

27,485 untis distributed in U.S., 4,371 units distributed internationally

Sold at

Worldwide Distribution - US (nationwide) and Canada

Description

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

Product

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

Manufacturer(s)

Arrow International Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →