Arrow International Inc recalls 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for

Recalled June 21, 2017 · FDA recall Z-2329-2017 · 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 units 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) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

Manufacturer(s)

Arrow International Inc

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