Skip to content
Recall Observatory FDA recall evidence

Device 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 adequate peripheral venous access.

Z-0910-2013

February 21, 2013

Class II

Product summary

Firm
Bard Access Systems
Event
Event 64425
Status
Terminated
Classification
Class II
Quantity
73 units
Official record key
device-enforcement:Z-0910-2013

Official wording

Reason: 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 due to the wrong size introducer being included with the kit.

Code information: Lot numbers: HUWI1379 and HUWI1380.

Distribution pattern: USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 due to the wrong size introducer being included with the kit.