WASHINGTON – Federal health officials announced the recall of 2 million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies.
The Food and Drug Administration said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.
The needles are used to access injection ports, which are devices implanted beneath the skin of patients who require frequent injections. The ports connect to a vein and allow easy delivery of chemotherapy, antibiotics and other injectable drugs.
Huber needles are designed to be non-coring, or to penetrate an injected material without retaining any of it.
However, a monthslong FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient's bloodstream. The problem can also damage the ports themselves, resulting in problems delivering drug therapy.
An inspection at Nipro's manufacturing plant in Japan found that 60 to 72 percent of the company's needles had the design problem, according to the FDA.
"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," said Dr. Jeffrey Shuren, FDA's director of medical devices.
Huber needles have been approved in the U.S. since 1984, according to the FDA.
FDA officials told reporters Tuesday they are working with 19 other manufacturers to determine if their needles have the same problem. The agency estimates 6 million Huber needles are sold in the U.S. each year.
According to FDA regulatory specialist Mary Brooks, there have been no reports of silicone shards in patients, though it may be difficult for doctors to identify the problem.
Tuesday's announcement was the second mass recall from Nipro Medical in less than a week. On Thursday the company recalled 15 lots of GlucoPro Insulin Syringes because of a defect that can cause the needles to detach.
FDA advised hospitals and doctors to stop using the Huber needles and return them to Los Angeles-based Exel International, which distributed the products in the U.S. The company can be reached at 1-800-940-3935.
A spokesman for Exel said the company hopes to wrap up the recall within 30 days.
The FDA made several recommendations to physicians when using other Huber needles, including: watching for signs of tissue or nerve damage in patients, which could be a sign of damage to an injection port. The agency also suggested throwing out the first syringe injected into a port, in an effort to discard any bits of silicone.