Z-1747-2020 Class I Terminated
FDA device recall Z-1747-2020 was initiated by Vascular Solutions, Inc. on March 16, 2020 and is designated Class I. Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection. The recall status is terminated (terminated June 18, 2024). Affected quantity: 30,877 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 16, 2020
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,877 units
Product Description
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reason for Recall
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Distribution Pattern
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.
Code Information
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