Diabetes Alert: Insulin Syringes Recalled
Company Recalls 471,000 ReliOn Insulin Syringes Because of Possible Mislabeling and Overdose Risk
Nov. 6, 2008 -- People with diabetes who use ReliOn insulin syringes should check
their syringe package because of an important recall.
Tyco Healthcare Group (Covidien) is recalling 4,710 boxes of the syringes --
with 100 syringes in each box -- that were sold at Wal-Mart and Sam's Club from
Aug. 1, 2008 through Oct. 8, 2008.
The reason for the recall: possible mislabeling and overdose risk.
"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," states an FDA news release.
The recall only applies to the following products:
- Product name: ReliOn Insulin Syringes -- 31 gauge 1 cc (with 100
syringes per box)
- Lotnumber: 813900 (on the back panel of the carton, or on the white
paper backing of each syringe's "peel pack")
- Product identification number: 38396-0403-02 (on the top panel upper
right-hand corner of the syringe box)
The FDA says some syringes labeled for use with U-40 insulin got packaged
with syringes for U-100 insulin.
The FDA notes that Tyco Healthcare recalled this lot of syringes in October,
and Wal-Mart and Sam's Club stores have posted information about the recall and
notified more than 16,500 customers about the recall.
For more information, call 866-780-05436 or visit the ReliOn recall web site for more
information. Customers will be provided with a replacement package.