Two Million Needles Recalled By FDA
The U.S. Food and Drug Administration recalled over two million needles made by Japanese firm Nipro Medical Corp. over fears they might introduce silicone fragments in patients’ bodies.
The FDA announced Tuesday that the firm had taken back products made between January 2007 and August 2009 after inspections in October last year showed between 60 and 72 percent of the needles were defective.
The two million needles that were distributed in the U.S. have now been recalled.
These needles are used to access ports that are implanted underneath the skin of chronically ill patients in order to withdraw blood or infuse medication repeatedly.
The FDA said October 2009 that after testing of Nipro facilities in Japan, they found that some of the needles were allowing pieces of the port’s silicone core to become dislodged.
Although no harm had been documented, FDA officials said they were concerned a piece of silicone could enter a patient’s bloodstream.
Only the needles produced by Nipro were found to frequently result in coring, although there are 20 different manufacturers that produce the product.
"We will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible," said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
The needles are a type known as Huber needles and were distributed by privately held Exel International. There were not any Exel officials available for comment.
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