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-0111-2021
- 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.
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