Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter

Recall date

August 31, 2020

Source

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

Recall number

Z-0110-2021

FDA classification

Class I

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria,…

Why it was recalled

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Langston Dual Lumen Catheter