WHO: Nipro Corp.
WHAT: The U.S. Food and Drug Administration said October inspections of Nipro facilities in Japan revealed problems with the company’s needles that could dislodge pieces of silicone or other foreign particles that could end up in a patient’s bloodstream.
HOW: Known as “Huber needles,” these are used for accessing ports implanted under the skin of chronically ill patients for repeated access to veins. The FDA inspections found 60 to 72 percent of Nipro needles tested had a defect that could break pieces of the port’s silicone core inside a patient.
WHAT’S BEING DONE: Nipro recalled 2 million needles distributed in the United States, and the FDA has banned the import of the needles until the malfunction is fixed.