Langston Dual Lumen Catheter.
Check against the official notice below — it lists the full affected range.
Vascular Solutions, Inc. is recalling 89,121 units of the Langston Dual Lumen Catheter (Model Number 5540) due to a hazard in which 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 multiple countries including Canada, Mexico, Australia, and various European nations. The recall involves numerous lot numbers, with specific lot and UDI information provided for identification.
The source document does not specify a remedy or recommended course of action for affected consumers.
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: 89,121 units Lot/code info: Model Number: 5540, UDI, 10841156100513, Lots 643376, 633647, 639516, 645032, 649315, 650991, 656191, 658151, 659443, 660590, 666438, 670586, 672660, 635207, 636898, 643051, 644573, 645360, 645482, 648481, 649729, 650018, 650873, 651457, 653053, 655645, 655738, 657627, 658250, 658824, 659122, 659217, 660910, 661139, 663039, 663344, 665098, 665099, 666559, 668703, 671743, 671948, 672894, 633211, 635208, 635542, 636901, 637832, 644015, 646106, 649078, 650765, 654190, 657517, 657680, 660717, 662903, 663138, 665303, 667164, 669190, 647786, 671427, 634423, 634247, 648043, 648963, 651920, 653863, 660823, 662493, 661257, 650369, 638953, 669199, 658438, 668701, 636284, 640938, 641222, 641543, 641679, 642031, 650023, 654010, 655128, 657030, 660075, 663281, 663790, 663854, 635805, 659362, 668303, 666966, 632018, 635209, 643835, 645118, 646247, 647482, 649456, 652176, 653319, 656554, 659630, 661863, 662824, 665234, 669602, 647370, 648337, 672813, 664087, 657243, 652097, 668095, 636471, 640676, 642373, 642520, 644650, 654890, 655460, 657866, 658018, 661474, 662053, 662133, 664449, 667465, 668934, 670503, 672130, 663791, 635280, 669402, 632020, 638198, 639892, 640034, 648603, 653565, 654889, 658984, 662642, 671202, 643542, 645481, 672349, 635541, 661707, 666332, 670144, 654514, 654657, 671004, 671633,637388,645031, 646641, 650606, 670299, 642928, 670865, 639414, 642178, 646110, 651524, 660199, 668094, 669591, 641060, 647014, 651163, 655869, 656727 ,647697, 635861, 640459, 666067, 667936,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.