Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
Vascular Solutions, Inc. is recalling 89,121 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability of serious adverse health consequences or death. The rubric specifies that FDA Class I recalls must be scored at least 4, but the source text does not explicitly report deaths or serious injuries, and the hazard is a mechanical defect during a specific procedure. However, the rubric states 'If the agency's own classification is FDA Class I... never go below 4.' Wait, the rubric says 'never go below 4' for FDA Class I. Let me re-read. 'If the agency's own classification is FDA Class I or USDA Class I, never go below 4.' Okay, so it must be 4 or 5. Since there are no reported deaths, it is 4.
Plain-English summary
Vascular Solutions, Inc. is recalling 89,121 units of the Langston Dual Lumen Catheter (Model Number 5540). The recall is due to a defect where the inner lumen of the catheter may separate from the hub during pressure injection.
The affected products were distributed domestically across the United States and internationally to numerous countries, including Canada, the United Kingdom, Germany, and Australia. The source text lists specific lot numbers and UDI codes associated with the recalled units.
Healthcare providers and consumers should stop using the affected catheters and contact Vascular Solutions, Inc. for further instructions or a replacement.
The recalled product
- Product
- Langston Dual Lumen Catheter.
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 89,121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: 5540
- UDI
- 10841156100513
- Lots 643376
- 633647
- 639516
- 645032
- 649315
- 650991
- 656191
- 658151
- 659443
- 660590
- 666438
- 670586
- 672660
- 635207
- 636898
- 643051
- 644573
Distribution
Part of a larger recall action
This product is one of 4 recalled by Vascular Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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See all →- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
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- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
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- HighVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
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