The FDA has announced 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 for Exelint International.

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.

These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

However, inspections conducted in October 2009 of Nipro facilities in Japan found that their needles 'cored' in 60 to 72% of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

The company said that there are more than two million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with 07, 08, 09.

The FDA has advised that the hospitals, clinics and patients who have needles from these lots, should immediately stop using these affected products and return any unused ones to Exelint International.

Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted it own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports. However, at this time only needles manufactured by Nipro have shown a high frequency for coring.

The agency has issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns.

Jeffrey Shuren, director of the center for devices and radiological health at FDA, said: “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.”

source:web of PBR