Terumo Medical Corporation recalls Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is…

Recall date

September 12, 2017

Source

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

Recall number

Z-0725-2018

FDA classification

Class II

Brand / firm

Terumo Medical Corporation

Sold / distributed

To be added.

Why it was recalled

The tucking depth feature of this catheter introducer is marginally outside the upper 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

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.