FDA-Device2020-10-28Class I
Langston Dual Lumen Catheter.
Vascular Solutions, Inc.
Hazard
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Sold states
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, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
Affected count
89,121 units
Manufactured in
6420 Sycamore Ln N, N/A, Maple Grove, MN, United States
Products
Langston Dual Lumen Catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0111-2021Don't want to check this manually?
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