Medical Devices
Information about Huber Needles
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.
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. The agency is continuing its investigation and will update the public if there are new developments.
This page lists the documents that explain this situation. It will be updated as new information becomes available.
List of Documents Associated with Huber Needles
Safety Investigation of Non-Coring (Huber) Needles: Updated October 25, 2010
October 25, 2010Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling
October 12, 2010- Performance Testing of Huber Needles for Coring of Port Septa, Journal of Medical Devices.
September 8, 2010 Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
August 26, 2010- Class 1 Recall Notice: Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch " Safety Huber Infusion Sets
February 26, 2010 FDA Announces Class I Recall of Certain Infusion Set Needles
January 26, 2010
