FDA Re****ts Nationwide Recall Of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care
professionals
and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot
of ReliOn sterile, single-use, disposable, hypodermic syringes with
permanently affixed hypodermic needles due to possible mislabeling. The
use
of these syringes may lead to patients receiving an overdose of as much as
2.5 times the intended dose, which may lead to hypoglycemia, serious
health
consequences, and even death.
The recall applies to the following lot number and product information:
-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin
Only ReliOn syringes from this lot number and labeled as 100 units for use
with U-100 insulin are the subject of the recall.
These syringes are distributed by Can-Am Care Corp and sold only by
Wal-Mart
at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart
requests
that all users of ReliOn 31-gauge, 1cc syringes return those labeled as
100
units for use with U-100 insulin from Lot Number 813900 to their local
Wal-Mart store or Sam's Club pharmacy. Customers will be provided with
replacement product.
The FDA urges patients and health care professionals to check their
syringe
packaging carefully for syringes labeled as 100 units for use with U-100
insulin from Lot Number 813900.
Consumers and health care professionals who suspect they have the recalled
product may also contact Covidien at 866-780-5436 or
http://www.relion.com/recall
for more information.
ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a
hypodermic needle attached to the tip of the syringe.
During the packaging process for this lot, some syringes labeled for use
with U-40 insulin were mixed with syringes labeled for use with U-100
insulin, then all packaged individually and in boxes as 100 units for use
with U-100 insulin.
The manufacturer has distributed 4,710 boxes in the recalled lot, which
equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart
stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.
Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of
syringes on Oct. 9, 2008, asking that any units of the affected product be
removed from inventory and placed in quarantine. Wal-Mart posted the
recall
announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web
site,
and sent letters to more than 16,500 customers notifying them of the
recall.
The manufacturer has received one adverse re****t related to a syringe from
this product lot.
Health care professionals and consumers may re****t serious adverse events
(side effects) or product quality problems with the use of this product to
the FDA's MedWatch Adverse Event Re****ting program either online, by
regular
mail, fax or phone.
--Online: http://www.fda.gov/MedWatch/re****t.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
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