FDA Issues Class I Recall of Infusion Set Needles

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelient Securetough+ Safety Huber Infusion Sets, manufactured by Nipro Medical Corp., the agency said.

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, according to the FDA.

Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring, the agency said, is related to design and manufacturing processes,

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009.