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, according to the release. 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 Oct. 2009 of Nipro facilities in Japan found that their needles “cored” 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, according to the report.
There are more than 2 million units impacted by this recall in distribution nationwide, according to the release. Recalled needles were manufactured from Jan. 2007 to Aug. 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:
Exel/Exelint Huber Needles Product Codes/Catalog Numbers:
26901
26902
26904
26906
26907
26908
26909
26911
26921
26922
26923
26924
26925
Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers:
With/Injection Site:
27940R
27941R
27944R
27945R
27946R
27948R
27949R
27950R
Without/Injection Site Product Codes/Catalog Numbers:
27954R
27955R
27958R
27959R
Exel/Exelint “SecureTouch +” Safety Huber Sets Product Codes/Catalog Numbers:
37854S
37855S
37858S
Hospitals, clinics and patients who have needles from these lists 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 healthcare professionals consider taking the following precautions, which will be posted on the 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.
Read the FDA’s release on the Huber infusion needle recall.
