Langston Dual Lumen Catheter
Check against the official notice below — it lists the full affected range.
Vascular Solutions, Inc. is recalling 1,680 units of the Langston Dual Lumen Catheter (Model Number 5515) due to a hazard where the inner lumen may separate from the hub during pressure injection. The affected catheters were distributed domestically across all 50 U.S. states plus Washington D.C. and Puerto Rico, as well as internationally to countries including Canada, Mexico, Austria, Australia, Belgium, France, Germany, Italy, and others. The recalled units are identified by specific lot numbers: 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, and 677058.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection. Distribution: 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, N Quantity: 1,680 units Lot/code info: Model Number: 5515, UDI 10841156100506 Lot Numbers: 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, 677058.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.