Radial Artery Catheterization Set recalled over foreign material

Recall date

July 10, 2017

Source

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

Official notice title

Arrow International Inc recalls Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial c…

Recall number

Z-0486-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

...

Why it was recalled

Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

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 Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.