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Federal health officials recall 2M medical needles for health risk

2010-01-27 04:42:16 (GMT) (Caymanmama.com - Business Health News News)

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Phoenix, Arizona (CaymanMama.com) — Nearly 2 million medical needles have been recalled by federal health officials due to a serious bodily injury risk.

The Food and Drug Administration announced Tuesday that the Japanese manufacturer Nipro Medical Corp. has issued a voluntarily recall of its Exel/Exelint Huber needles, made between January 2007 and August 2009.

The medical needles are used to access injection ports, which are devices implanted under the skin of patients who require frequent injections, such as chemotherapy, antibiotics and other medications given via injections.

Huber needles are designed so that they penetrate an injected material without retaining any of it, otherwise known as “coring”.

An investigation carried out by the FDA found that the Huber the needles can push silicone particles from the ports, potentially dislodging them into the patient’s bloodstream. The issue can also damage the injection ports themselves, which could result in issues delivering the injectable drugs.

During an inspection at Nipro’s manufacturing plant in Japan, the FDA identified 60 to 72 percent of the company’s needles with the design defect.

“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.

The FDA approved the Huber needles in the U.S. in 1984.



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