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 Corporation for Exelint International Corporation. 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. The FDA stated that defective needles have at times severed pieces of silicone from related devices that then could potentially enter a patient’s blood stream. 

There are more than 2 million units impacted 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:

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. All questions regarding this recall should be directed to:

Attn: Armand Hamid
EXEL International
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
Tel. 800-940-3935
Fax 800-308-5048
E-mail: info@exelint.com

View the FDA announcement and more information regarding the recall.