Device product
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Z-1747-2020
Product summary
- Event
- Event 85350
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30,877 units
- Official record key
device-enforcement:Z-1747-2020
Official wording
Reason: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
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
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.
Derived failure modes
-
Unknown
The inner lumen of the Langston catheter may separate from the hub during pressure injection.