Vascular Solutions, Inc.: Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

Is my product affected?

Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

• UPC 10841156100513

Check against the official notice below — it lists the full affected range.

What happened

Vascular Solutions, Inc. is recalling 30,877 units of the Langston Dual Lumen Catheter 6F Model 5540 worldwide, including distribution throughout the United States and multiple countries in Europe, Asia, Africa, Australia, Canada, and Mexico. The catheter is used to deliver contrast medium during angiographic studies. The inner lumen of the catheter may separate from the hub during pressure injection, which is the reason for the recall.

The affected product includes Model 5540 catheters with UDI 10841156100513 across 61 specific lot numbers ranging from 651278 through 662824. The recall notice does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Details from the source

Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection. Distribution: Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom. Quantity: 30,877 units Lot/code info: Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151, 658250, 658438, 658541, 658671, 658824, 658984, 659122, 659217, 659362, 659443, 659630, 659855, 660075, 660199, 660288, 660397, 660590, 660717, 660823, 660910, 661139, 661257, 661474, 662824

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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