Reported Jul 9, 2014 · Terminated
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring…
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. · 6464 Sycamore Ct N · Maple Grove, MN · 55369-6032
Is this the product you have?
- Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
- Lot codes and dates
- Lot Numbers
569436569437569962569963569964569965570177570178570337570338570339570340570341570504570505570506570507570592570593570674570675570744570745570746570836570926570927570928570929571099571100571101571102571103571350571412571413571414571415and 571727
- Lot Numbers
- Amount recalled
- 8,580 total (US 5714)
Where it was sold
Why it was recalled
Stop using this product now
The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Using this product could cause serious injury, illness or death — stop using it now.
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