TUESDAY, Jan. 26 (HealthDay News) -- The U.S. Food and Drug Administration has issued 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.
The recall follows FDA inspections in October 2009 that found the needles, which are used to access ports implanted under the skin of chronically ill patients, shaved slivers or cores of silicone off the ports in 60 to 72 percent of tests. To date, the FDA has not received reports of any adverse events related to this "coring" depositing silicone in patients; however, the FDA said such instances may be underreported because of the difficulty of attributing adverse events to the defective Huber needles.
The Class 1 recall, which is the most serious category of recall, covers more than 2 million units manufactured by Nipro from January 2007 to August 2009, and distributed nationwide. Currently, only the Nipro products have been implicated, but the FDA has issued a letter to manufacturers of other Huber needles to spotlight their concerns. The recall comes a day after Nipro voluntarily recalled another product, the GlucoPro Insulin Syringe, because of a defect that may cause the needle to detach from the syringe.
"The agency's laboratory work helped determine the coring problem, and we will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in the Jan. 26 press release.
Press Release
FDA MedWatch Adverse Event Reporting
