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

Recall date

May 9, 2017

Source

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

Recall number

Z-2329-2017

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) 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