Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
Vascular Solutions is recalling 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 involves a structural defect in a medical device that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Vascular Solutions, Inc. is recalling 30,877 units of the Langston Dual Lumen Catheter 6F Model 5540. This medical device is used for the delivery of contrast medium in angiographic studies.
The recall was initiated because the inner lumen of the catheter may separate from the hub during pressure injection. The affected units were distributed worldwide, including in the United States, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 30,877
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 5540
- UDI 10841156100513
- Lots 651278
- 651457
- 651920
- 652097
- 652176
- 652459
- 652628
- 652777
- 653053
- 653319
- 653443
- 653565
- 653776
- 653863
- 654010
- 654190
- 654340
- 654514
Distribution
Distributed nationwide across the United States.
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