FDA-Device2013-03-13Class II
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 for use in patients that lack adequate peripheral venous access.
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.
Sold states
USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
Affected count
195 units.
Manufactured in
605 North 5600 West, N/A, Salt Lake City, UT, United States
Products
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 for use in patients that lack adequate peripheral venous access.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2013Don't want to check this manually?
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