ReliOn Insulin Syringes used by diabetics have been recalled by Tyco Healthcare Group LP (Covidien). The Food & Drug Administration (FDA) said the 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 involves one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles that may be mislabeled. 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.
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.
The recalled ReliOn syringes were 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.
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.
Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.
<You can leave a response, or trackback from your own site.
