Concentric Medical Inc recalls Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Cathe…

Recall date

August 19, 2015

Source

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

Recall number

Z-0116-2016

FDA classification

Class II

Brand / firm

Concentric Medical Inc

Sold / distributed

US Distribution to one location in KY.

Why it was recalled

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

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

What was recalled

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.