FDA-Device2014-07-09Class I
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Vascular Solutions, Inc.
Hazard
The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Sold states
Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
Affected count
8,580 total (US 5714)
Manufactured in
6464 Sycamore Ct N, Maple Grove, MN, United States
Products
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1981-2014Don't want to check this manually?
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