The AP (1/27, Perrone) reports, “Federal health officials announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients’ bodies.” The FDA “said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.” Doctors, nurses, and patients should not be using these needles under any circumstances.
Bloomberg News (1/27, Peterson) reports that the “defect…might lead to fatal blockages of the main artery of the lung, the [FDA] said.” The needles, which are intended “to give food and medicine to chronically ill patients,” can “dislodge ‘cores,’ or slivers of silicon, from ‘ports’ under the skin and release the material into the bloodstream, FDA officials said.” Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA’s Center for Devices and Radiological Health, said the “defective needles…may cause tissue damage and inadequate drug delivery.”
Regulators have not received reports that the needles released silicon or other foreign chemicals into patients, but the defect is difficult for doctors to detect, Dow Jones Newswire (1/27, Favole) reports.
CNN (1/27, Young) reports that the FDA “said anyone using the products should stop immediately and return any unused needles to Exelint.” The agency indicated that it is conducting investigations “of needles from 20 companies,” of which 10 have already been completed. “The FDA said it has sent letters to all Huber manufacturers asking them to address any design or manufacturing problems.”
About the author:
Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area. The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims. Mr. Zambri has also been named a “Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America.
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