WASHINGTON, Jan 26 (Reuters) - Japanese company Nipro Corp (8086.T) has recalled 2 million needles distributed in the United States for withdrawing blood, injecting medicines and other purposes, U.S. health officials said on Tuesday.
Stocks | Regulatory News
The needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins.
The Food and Drug Administration said October 2009 inspections of Nipro facilities in Japan found problems with the companies' needles that could allow pieces of the port's silicone core to become dislodged.
The inspections found 60 percent to 72 percent of Nipro's needles tested had that problem, the FDA said.
No harm has been documented, but FDA officials told reporters on a conference call they were concerned a piece of silicone could enter a patient's bloodstream.
The needles are a type known as Huber needles and were distributed by privately held Exel International.
Nipro subsidiary Nipro Medical Corp referred questions to Exel. An Exel official could not immediately be reached for comment.
Details about the recalled needles were posted on the FDA website here
(Reporting by Lisa Richwine, editing by Leslie Gevirtz)
The Japanese company Nipro has voluntarily recalled two million needles in the US used for withdrawing blood and medicine injections, health officials said today.

The affected items are Huber needles, manufactured in Japan and distributed by Exelint International Corporation. The needles are intended to access ports placed under chronically ill patients' skin, for frequent access to veins.

According to the Food and Drug Administration (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone in the port to be dislodged. 60%–72% of tested needles had that problem.  In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.

"There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009," read a statement on the FDA's website. "... Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation."

"At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring ... However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events," the statement continued.

Exelint has not yet issued a public statement about the report from the FDA.