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.
The 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.