Langston Dual Lumen Catheter.
Check against the official notice below — it lists the full affected range.
Vascular Solutions, Inc. is recalling 2,990 units of the Langston Dual Lumen Catheter (Model Number 5550) because the inner lumen may separate from the hub during pressure injection. The affected products were distributed domestically across all 50 U.S. states, Washington D.C., and Puerto Rico, as well as internationally to multiple countries including Canada, Mexico, Austria, Australia, Belgium, France, Germany, Ireland, Italy, and others. The recalled units are identified by specific lot numbers: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, and 635885.
The source does not specify a remedy for 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: 2990 units Lot/code info: Model Number: 5550, UDI 10841156100537 total 2990, Lots: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, 635885.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.