FDA Device recall Z-1747-2020
Langston Dual Lumen Catheter 6F Model 5540
- FDA Device
- Class I
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class I recall of Langston Dual Lumen Catheter 6F Model 5540 by Vascular Solutions, citing the inner lumen of the Langston catheter may separate from the hub during pressure injection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1747-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-03-16 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vascular Solutions |
| Distribution | US |
Product
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reason
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Identifiers
| code_info | Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 65…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2020%22
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