Japanese company recalls two million needles in US
Wednesday, January 27, 2010
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.
- "Nipro recalls 2 mln medical needles in U.S." — , January 26, 2010
- Saundra Young. "FDA recalls more than 2 million needles used in port implants" — , January 26, 2010
- "FDA Announces Class I Recall of Certain Infusion Set Needles" — , January 26, 2010