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Bard Access Systems recalls Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer syste
Recalled March 13, 2013 · FDA recall Z-0910-2013 · Bard Access Systems
Hazard
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. · FDA Class II
Units
73 units
Sold at
USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
Description
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.
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.
Manufacturer(s)
Bard Access Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →