Class I Recall Issued for Exel/Exelint Huber Infusion Set NeedlesJan 26, 2010 | Parker Waichman LLP
Exel/Exelint Huber infusion set needles manufactured by Nipro Medical Corporation for Exelint International Corporation have been recalled for a "coring" issue. There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the product codes or catalog numbers noted in the Food & Drug Administration (FDA) news release.
Hospitals, clinics and patients who have needles from the recalled Huber needles should immediately stop using these affected products and return any unused products to Exelint International Corporation.
Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. The recall is being conducted due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted.
Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted it own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports. However, at this time only needles manufactured by Nipro have shown a high frequency for coring. Inspections conducted in October 2009 of Nipro facilities found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate and will update the public if there are new developments.
At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. 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.
Class I recalls are the FDA most serious recall action, and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.