A Class I recall has been issued for <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Exel/Exelint Huber infusion set needles manufactured by Nipro Medical Corporation for Exelint International Corporation. Class I recalls are the Food & Drug Administration’s (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.
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 â€œcoredâ€ 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.
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 â€œ07,â€ â€œ08,â€ â€œ09,â€ and one of the product codes or catalog numbers noted in the FDA news release.
Hospitals, clinics and patients who have the recalled needles should immediately stop using these affected products and return any unused products to Exelint International Corporation.
The FDA continues to work closely with all 20 manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures. While a more thorough investigation of this situation continues, the FDA recommends that health care professionals consider taking the following precautions, which will be posted on the FDAâ€™s Web site, when accessing implanted ports with Huber needles:
â€¢ Avoid flushing the syringe when initially confirming needles patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patientâ€™s body, and could lead to serious adverse events.
â€¢ When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
â€¢ Watch for signs and/or symptoms that may indicate damage to the portâ€™s septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area.
â€¢ Patients should continue to follow their doctorâ€™s recommendations for receiving treatment.