FDA Announces Class I Recall of Over Two Million
Huber Infusion Set Needles
Huber needles used in implanted ports to withdraw
blood, inject medications, and other solutions
Jan. 27, 2010 - The Food and Drug Administration
yesterday 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.
Inspections conducted in October 2009 of Nipro
facilities in Japan found that their needles “cored” in 60 to 72 percent
of tests. The reason for this coring is related to design and
manufacturing processes, which the FDA continues to investigate.
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.
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. However, at this time only
needles manufactured by Nipro have shown a high frequency for coring.
The agency is continuing its investigation and will update the public if
there are new developments.
At this time, the FDA has not received any adverse
event reports related to silicone foreign bodies released in patients
from Huber needle coring.The agency received only reports of port
leakage. However, because it may be very difficult for clinicians to
associate adverse patient outcomes with the use of defective Huber
needles, there may be under-reporting of events.
The agency has issued a letter to manufacturers of
other Huber needles to address design and manufacturing concerns.
“The agency’s laboratory work helped determine the
coring problem, and we will continue to work with manufacturers to
address coring issues as quickly and thoroughly as possible,” said
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and
Radiological Health.
The FDA continues to work closely with all 20
manufacturers of Huber needles to understand the potential causes for
coring and identify corrective measures. While a more thorough
investigation of this situation continues, the FDA recommends that
health care professionals consider taking the following precautions,
which will be posted on the FDA’s Web site, when accessing implanted
ports with Huber needles:
Avoid flushing the syringe when initially
confirming needles patency upon accessing the port. If the needle has
cored the port, flushing may introduce the core into the patient’s body,
and could lead to serious adverse events.
When possible, upon accessing the port, consider
aspirating a small amount of blood from the port after septum puncture,
then discard the syringe with its contents. This step may recapture the
silicone sliver. If the needle becomes clogged when attempting to
aspirate, remove the needle, discard it and select a new one.
Watch for signs and/or symptoms that may indicate
damage to the port’s septum, such as medication leakage resulting in
inadequate therapy delivery, along with tissue, nerve and/or muscle
damage; and redness of the surrounding area.
Patients should continue to follow their doctor’s
recommendations for receiving treatment.
Direct all questions concerning this recall 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
Health care professionals and consumers may report
serious adverse events (side effects) or product quality problems with
the use of these products to the FDA's MedWatch Adverse Event Reporting
program either online, by regular mail, fax or phone.
Online:
http://www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500
available at:
http://www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088
FDA Information on Nipro Huber Needle Recall:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87821
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87830
