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U.S. Food and Drug Administration

FDA Announces Class I Recall of Certain Infusion Set Needles

Published in Medical Letter on the CDC and FDA, February 14th, 2010

The U.S. Food and Drug Administration announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "SecureTouch+" Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

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