Merit Medical Systems, Inc. recalls Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath I…

Recall date

June 4, 2015

Source

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

Recall number

Z-1826-2015

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.

Why it was recalled

Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

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

What was recalled

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.