Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Recall date
- March 16, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1747-2020
- FDA classification
- Class I
- Brand / firm
- Vascular Solutions, Inc.
- Sold / distributed
- Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
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 6F Model 5540. For delivery of contrast medium in angiographic studies
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