2010-01-29
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.
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