WASHINGTON – The U.S. Food and Drug Administration on Tuesday requested a recall of about 2 million medical needles manufactured by Japanese medical supplier Nipro Corp. over concerns that the needles could allow silicone particles to enter a patient’s bloodstream.
The FDA said it has not received any reports of health problems related to the Huber needles.
The needles are used on a patient to repeatedly access the veins for drips through a device called a silicon port implanted under the skin.
The agency is concerned that silicone from the needles could come off when they are inserted to the port, allowing the substance to enter the bloodstream.
Needles manufactured from January 2008 to last August are subject to the recall, the FDA said.
The health ministry said the move is based on tests conducted under more stringent conditions than usual and no problems have been reported domestically.
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