Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size
Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a manufacturing error (wrong size introducer) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems. The recall is due to the wrong size introducer being included with the kit.
The affected products are designed for long-term vascular access in patients who lack adequate peripheral venous access. The recall covers 73 units with lot numbers HUWI1379 and HUWI1380. These products were distributed nationwide in the USA as well as in Europe, Belgium, Australia, and Latin America.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the affected products are found, they should be removed from use and returned to Bard Access Systems according to the company's instructions.
The recalled product
- Product
- Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequat
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 73
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 (1)
- Lot numbers: HUWI1379 and HUWI1380.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bard Access Systems 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.
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