Millions of Huber Needles Recalled

Over two million Huber needles, which are used in conjunction with implanted ports to deliver medications by infusion in patients with chronic illnesses such as cancer, are voluntarily being recalled because inspections of Nipro facilities in Japan, a manufacturer of the needles, found 60% to 72% of needles cored in tests, increasing the risk of port leakage or silicone entering the veins. This is a Class I recall, which is the most severe type of FDA recall, as there is a potential for serious injury or death.

Over two million Huber needles, which are used in conjunction with implanted ports to deliver medications by infusion in patients with chronic illnesses such as cancer, are voluntarily being recalled because

inspections of Nipro facilities in Japan, a manufacturer of the needles, found 60% to 72% of needles cored in tests, increasing the risk of port leakage or silicone entering the veins. This is a Class I recall, which is the most severe type of FDA recall, as there is a potential for serious injury or death.

In the United States, Nipro’s Huber needles are distributed by Exelint. The needles subject to the recall were manufactured between January 2007 and August 2009 and have a lot number that begins with “07,” “08,” “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, 26925

· Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers With/Injection Site: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R

· Without/Injection Site Product Codes/Catalog Numbers: 27954R, 27955R, 27958R, 27959R

· Exel/Exelint “SecureTouch +” Safety Huber Sets Product Codes/Catalog Numbers: 37854S, 37855S, 37858S

There are 20 manufacturers of Huber needles, but so far only Nipo’s needles have shown a high frequency for coring, which appears to stem from design and manufacturing issues. The FDA has issued letters to other Huber manufacturers regarding these issues and continues to conduct more thorough investigations into the coring issue of Nipo’s needles. In the meantime, the FDA recommends that health care professionals take the following precautions when accessing implanted ports with Huber needles:

· Avoid flushing the syringe when initially confirming needles patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patient’s body, and could lead to serious adverse events.

· When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it, and select a new one.

· Watch for signs and/or symptoms that may indicate damage to the port’s septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve, and/or muscle damage; and redness of the surrounding area.

· Patients should continue to follow their doctor’s recommendations for receiving treatment.

Click here for the FDA’s recall alert.