Personal Injury Law

FDA Issues Class I Recall of Medical Needles

By Greg Owen

The Food and Drug Administration announced the recall of 2 million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies.

Federal officials 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 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.

Huber needles have been approved in the U.S. since 1984, according to the FDA.

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.

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.

Full post as published by Glendale Personal Injury Lawyer on January 27, 2010 (boomark / email).