Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
Vascular Solutions, Inc. is recalling 1,745 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Vascular Solutions, Inc. is recalling 1,745 units of the Langston Dual Lumen Catheter. The recall is due to a defect where the inner lumen of the catheter may separate from the hub during pressure injection.
The affected product is Model Number 5545. The recall covers specific lots including 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, and 668503. The UDI for the product is 10841156100520.
The product was distributed domestically across numerous US states and territories, as well as internationally to countries including Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Langston Dual Lumen Catheter.
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1,745
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 (18)
- Model Number: 5545
- UDI 10841156100520 total 1745
- Lots: 634357
- 645111
- 649740
- 650126
- 655647
- 657411
- 661790
- 666866
- 673313
- 638819
- 650127
- 659802
- 672219
- 675001
- 638547
- 668503.
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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