Arrow International Inc recalls Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier…

Recall date

November 14, 2017

Source

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

Recall number

Z-1158-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

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

What was recalled

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.