Reported May 6, 2020 · Terminated
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Vascular Solutions, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vascular Solutions, Inc. · 6420 Sycamore Ln N · Maple Grove, MN · 55369-6013
Is this the product you have?
- Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 5540— — 10841156100513UDI 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 - Amount recalled
- 30,877 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Using this product could cause serious injury, illness or death — stop using it now.
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