Langston Dual Lumen Catheter.
Check against the official notice below — it lists the full affected range.
Vascular Solutions, Inc. is recalling 1,745 units of the Langston Dual Lumen Catheter (Model Number 5545) because the inner lumen may separate from the hub during pressure injection. The affected catheters were distributed domestically across all U.S. states and territories, as well as internationally to countries including Canada, Mexico, Australia, and multiple European nations. The recalled units span 16 specific lot numbers.
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: 1,745 units Lot/code info: Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.