FDA Announces Class I Recall of Certain Infusion Set Needles
Huber Needles Are Used in Implanted Ports to Withdraw Blood, Inject Medications, and Other Solutions
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets manufactured by Nipro Medical Corp. for Exelint International Corp.
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. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.
Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles "cored" in 60% to 72% of tests. The reason for this coring is related to design and manufacturing processes that the FDA is continuing to investigate.
There are more than 2 million units affected 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 following product codes or catalog numbers:
FDA says that health care providers and patients who have needles from these lists should immediately stop using them and return any unused products to Exelint International Corp.
:: All questions concerning this recall should be directed to:
Attn: Armand Hamid
5408 West Centinela Ave.
Los Angeles, CA 90045-1504
Ph: (800) 940-3935
Fax: (800) 308-5048
Following hospital reports to 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. The agency is continuing its investigation and will update the public if there are new developments.
At this time, FDA says it 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. In addition, FDA has issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns.
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 FDA's Web site, when accessing implanted ports with Huber needles:
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 patient's body and could lead to serious adverse events.
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.
Watch for signs and/or symptoms that may indicate damage to the port'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.
Patients should continue to follow their doctor’s recommendations for receiving treatment.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.