Huber Infusion Set Needle Recall: Risk of Silicon Contamination
The FDA has notified healthcare professions about a recall involving about 2 million Exel/Exelint Huber needles, Exel/Exeling Huber Infusion Sets and Excel/Exelint “Securetouch” Safety Huber Infusion Sets. The Huber infusion set needles have the potential to push pieces of silicone into a patient’s body, potentially causing serious injury.
The Class 1 recall affects was announced on January 26 for infusion needles manufactured by Nipro Medical Corporation for Exelint International Corporation. Inspectors discovered that the needles can “core” part of the silicon membrane that the needles are pushed through when used with port implants, potentially introducing the substance into the patient’s bloodstream. A Class 1 recall means that the defect has the potential to cause severe injury or death.
The FDA has received no adverse event reports concerning the defective needles, but warns that it may be difficult for health care professionals to connect adverse patient events with the defective needles. However, the FDA has received reports of ports leaking, which is a sign of coring.
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Learn MoreThe defect was discovered by inspectors performing a review of a Nipro production facility in Japan. The needles are used to inject various medications into ports implanted in a patient’s skin. These ports have silicon membranes to prevent leakage of medication or blood that the needle is pushed through.
Huber needles are supposed to be designed to pierce the membrane without removing any of the silicon material. FDA inspectors found that Nipro-manufactured Huber needles cored out a small piece of silicone from the membrane in 60 to 72 percent of tests.
The recalled needles were manufactured between January 2007 and August 2009, with lot numbers that begin with “07,” “08,” and “09.” A full list of affected product codes and catalog numbers is available in the FDA’s recall notice.
Huber needles are manufactured for Exelint by 20 companies, and over 6 million Huber needles are sold in the U.S. each year. The FDA said some needles from other manufacturers showed signs of coring on occasions, but after testing, the FDA has determined that only the Nipro-produced needles showed a regular tendency to core membranes.
Any health care facilities, professionals or patients who have needles affected by this recall should immediately stop using then and return any unused needles to Exelint International Corporation.
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2 Comments
JeffrieJune 2, 2010 at 9:39 pm
I have had several symptoms that I have suffered through that could not and still can not explain. I recently found this FDA notice from my former health care provider after had many injections over years with these recalled Exel Corp. needles. As a retired health care provider I feel I now have an answer ( I thought I was crazy with all these unexplained complaints and no real single or substan[Show More]I have had several symptoms that I have suffered through that could not and still can not explain. I recently found this FDA notice from my former health care provider after had many injections over years with these recalled Exel Corp. needles. As a retired health care provider I feel I now have an answer ( I thought I was crazy with all these unexplained complaints and no real single or substantive reason). This certainly does not make me feel any better with the additional pain I now have to deal with. I thought one severe medical problem with chronic severe pain would be enough for me in my life. I guess not. These huge medical companies can do what they wish and we (the lab rats) just have to hope we end up faring well in the deal. This news is very sad (and ironic) and disappointing to find.
teresaFebruary 12, 2010 at 5:39 pm
As if fighting a chronic illness wasn't enough, NOW THIS....I 've had OVER 40 HUBER NEEDLES pushed thru two different port sites, the first failed (for unknown reasons at the time)..the second implant ended with disasterous infection (life threatening) and the inability to have another IV central line..In addition to the horrid sufferings of the pancreatic disease I have, other bizarre symptoms ha[Show More]As if fighting a chronic illness wasn't enough, NOW THIS....I 've had OVER 40 HUBER NEEDLES pushed thru two different port sites, the first failed (for unknown reasons at the time)..the second implant ended with disasterous infection (life threatening) and the inability to have another IV central line..In addition to the horrid sufferings of the pancreatic disease I have, other bizarre symptoms have been occuring.. I am sure now , that it is silicone Leeching out of my skin and kidneys..Lucky for the manufacturers MOST recipients of these needles are already DEAD and it wont be long until the rest are!