FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets due to ‘coring,’ the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted). The recalled needles were manufactured from January 2007 to August 2009 by Nipro Medical Corporation. A full list of the recalled product codes is available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198676.htm.
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. Healthcare facilities and patients in possession of the recalled needles should stop using them immediately.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198728.htm.