Bard Access Systems Recalls Hickman and Leonard 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, and the defect involves a wrong size component in a medical device kit. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Bard Access Systems is recalling two lots of Hickman 9.0 French Dual Lumen Catheters and one lot of Leonard 10.0 French Dual Lumen Catheters. These products include a SureCuff Tissue Ingrowth Cuff and a Peel-Apart Percutaneous Introducer System. The recall is being conducted because the wrong size introducer was included with the kits.
The affected products are identified by lot numbers HUWI1379 and HUWI1380. The recall covers 195 units that were distributed nationwide in the United States, as well as in Belgium, Australia, and Latin America. These catheters are designed for long-term vascular access in patients who lack adequate peripheral venous access.
Healthcare providers and patients should check their inventory and records for the specific lot numbers listed in this recall. If the affected products are in use or stock, they should be removed from service and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and fo
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 195
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Bard Access Systems
See all →- ModerateBard Access Systems Recalls StatLock Catheter Stabilization Devices
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30
Same hazard · wrong size component
See all →- ModerateBlood pressure cuff bladder kits recalled for containing the wrong size bladder
FDA (Devices) · 2025-12-10
- ModerateAltivate Reverse Torx Peripheral Screw package labeling mismatch
FDA (Devices) · 2025-07-02
- HighAngioDynamics Recalls VenaCure EVLT NeverTouch Procedure Kits Due to Sizing Error
FDA (Devices) · 2013-06-05
- ModerateBard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size
FDA (Devices) · 2013-03-13