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Credit: FDA

April 30, 2020: Vascular Solutions, Inc. Issues Recall for Langston Dual Lumen Catheter Product Due to Risk of Separation During Use

Langston Dual Lumen Catheter Recall News – Vascular Solutions, Inc. (Vascular Solutions) has issued a recall for its Langston Dual Lumen Catheter product due to the potential for separation during use.

Langston Dual Lumen Catheter Recall Information

On April 30, 2020, Vascular Solutions ordered a recall of its Langston Dual Lumen Catheter product due to the risk of the inner catheter separating during use.

The Langston Dual Lumen Catheter is utilized by clinicians to see internal body structures by way of rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests (angiographic studies). The affected device can also measure pressure within the blood vessel.

Per the announcement,

If the inner catheter separates, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death. If the inner catheter separates outside of the patient’s body, the dye could spray the doctor and lead to an infection that may require the doctor to receive treatment.

The Langstone Dual Lumen Catheter affected product information is as follows:

  • Model Number: 6F 5540
  • Manufacturing Dates: June 22, 2019 to December 02, 2019
  • Distribution Dates: July 12, 2019 to March 10, 2020
  • Devices Recalled in the U.S.: 4,304
  • 64 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.

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