More than two million Huber needles -- about a third of the number used in the U.S. with implanted ports to treat chronic diseases -- have been recalled, the FDA announced.
The needles can cut the resealing silicone septum of the ports and possibly send slivers of the material into the body, with the potential to cause embolisms and other damage, according to Mary Brooks, RN, of the FDA's Center for Devices and Radiological Health.
The material could also lodge in the needle, restricting the flow of medication to the patient.
The recall affects needles made between January 2007 and August 2009 by Japan's Nipro Medical Corp. and imported by Exelint International Corp., of Los Angeles.
The recalled needles have lot numbers that begin with either 07, 08, or 09, and one of the following product codes or catalog numbers:
* Exel/Exelint Huber Needles Product Codes/Catalog Numbers: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922,26923, 26924, and 26925
* Infusion Sets Product Codes/Catalog Numbers With/Injection Site: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, and 27950R
* Infusion Sets Product Codes/Catalog Numbers Without/Injection Site: 27954R, 27955R, 27958R, and 27959R
* Exel/Exelint "SecureTouch +" Safety Huber Sets Product Codes/Catalog Numbers: 37854S, 37855S, and 37858S
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198676.htm
