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
Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers
Without/Injection Site Product Codes/Catalog Numbers:
Exel/Exelint “SecureTouch +” Safety Huber Sets Product Codes/Catalog Numbers:
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
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
View the FDA announcement and more information regarding the recall.