Intravenous news: The U.S. Food and Drug Administration today 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.
Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles â€œcoredâ€ in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.
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