Source: US Food and Drug Administration
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Vascular Solutions, Inc. Langston Dual Lumen Catheter
- Lot Numbers: Lots distributed between July 12, 2019 and March 10, 2020
- Model Number: Model 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
- Date Initiated by Firm: March 16, 2020
The Vascular Solutions, Inc. Langston Dual Lumen Catheter is used for the rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests (angiographic studies) to allow clinicians to see internal body structures. The device also measures pressure within the blood vessel.