A Class 1 recall has been issued on certain types of Huber safety needles because they may produce “cores” when inserted into ports. These cords may lead to potentially fatal infection, damage or death of tissue, swelling or other serious health consequences as they travel through blood vessels into the patient’s lungs. The recall affects lots of Huber needles manufactured by Multi-Med, Inc., and Navilyst Medical, Inc. A complete list can be found on the FDA website.

A class 1 recall is the most serious type of recall issued by the Food and Drug Administration (FDA) and involves products in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Huber needles are used on vascular access ports implanted in patients in need of repeated intravenous therapy. The recall was issued after an FDA investigation, which followed hospital reports of leakage after accessing the port with a Huber needles labeled to be non-coring. The FDA concluded that 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.

The FDA recommends that health care professionals immediately discontinue use of the recalled products. Any adverse events with this or any other medical device or product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.