Arrow International Inc recalls Radial Artery Catheterization Kit; Model: AK-04120

Recall date

October 26, 2017

Source

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

Recall number

Z-1284-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US nationwide distribution, including Puerto Rico.

Why it was recalled

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

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

What was recalled

Radial Artery Catheterization Kit; Model: AK-04120