Millions of Huber Needles Recalled
Earlier this year, the FDA recalled 2 million Huber needles manufactured between January 2007 to August 2009 by Nipro Medical Corporation and distributed by Exelint International Corporation.
The Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for infusion of medication, among other things. They are used to treat diseases ranging from sickle cell anemia to breast cancer to osteoporosis. The needles can cut into ports and possibly send slivers of the material in the port into the body. This is a very serious product defect and could cause grave damage to persons, according to Marc J. Bern & Partners.
The needles subject to recall include the following:
• Exel/Exelint Huber needles;
• Exel/Exelint Huber infusion sets; and
• Exel/Exelint Securetouch+ safety Huber infusion sets.
A class 1 level recall is the strongest recall level issued by the FDA. Inspections conducted in October 2009 of the Nipro facilities in Japan found that 60% to 72% of tested needles demonstrated “coring,” according to the FDA alert sent Tuesday from MedWatch, the FDA’s safety information and adverse event reporting program.
The FDA advises healthcare professionals to take the following precautions when using any type of Huber needle (ie, not just those manufactured by Nipro) in conjunction with normally operating ports:
• Avoid flushing the syringe when confirming patency of the needle on accessing the port, as it may introduce a silicone core into a patient’s body.
• Consider aspirating blood after accessing the port and then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged, use a new one.
• Watch for indications of damage to the port’s septum. These include medication leakage, resulting in inadequate dosing as well as tissue damage, and localized erythema.
No adverse events related to silicone foreign bodies released in patients from Huber needle coring have been reported yet. “The agency received only reports of port leakage,” they state in a written release. “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.”
If you or a loved one feel you may have been harmed from using a needled that has “cored,” you may be entitled to compensation. Marc J. Bern & Partners and its professional team of lawyers can evaluate your situation and determine the next steps to gain justice for you and your family.
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