Merit Medical Systems, Inc. recalls Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percut…

Recall date

September 12, 2019

Source

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

Recall number

Z-1956-2020

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

US Nationwide distribution in the state of MI.

Why it was recalled

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

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

What was recalled

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.