Langston Dual Lumen Catheter 6F recall
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Why was Langston Dual Lumen Catheter 6F recalled?
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Recalling firm
- Vascular Solutions, Inc.
- Quantity
- 30,877 units
- Distribution
- 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.
- Recall date
- May 6, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)