The Food and Drug Administration (FDA) has notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core traveling through blood vessels into the patient’s lungs. These issues may potentially cause death.

Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A “coring” Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly.

Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted its own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports. The agency is continuing its investigation and will update the public if there are new developments.

Clinicians are advised to immediately discontinue use of the recalled products. If you must use the kit, consider using an alternative, unaffected non-coring needle, if possible. However, if you do not have an alternate and unaffected non-coring needle, consider performing the following flushing procedures of the port as recommended by the FDA:

• Avoid flushing the syringe when initially confirming needle patency on 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, on 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.

1. Food and Drug Administration (FDA). Medical Devices. Medical Device Safety. Safety Investigation of Non-Coring (Huber) Needles. Updated August 25, 2010. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm198766.htm. Accessed August 31, 2010.

Posted in News Service
This entry was posted on Tuesday, August 31st, 2010 at 12:00 pm.