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
1,680 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-0110-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief