Arrow International Inc recalls Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integra…

Recall date

December 12, 2019

Source

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

Recall number

Z-0844-2020

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US distribution to SC

Why it was recalled

The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

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

What was recalled

Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.