Covidien, formerly Tyco Health Care, has recalled one lot of ReliOn disposable insulin syringes because of mislabeling. Some of the U-40 syringes in this lot were mistakenly labeled as U-100 syringes. Patients using U-100 insulin could experience a serious overdose if they used one of these mislabeled U-40 syringes, and that could lead to severe hypoglycemia and possibly death.
The recalled lot is number 813900. These 1 cc, 31 gauge insulin syringes, which were mistakenly labeled U-100, were sold only by Wal-Mart and Sam's Club, under the ReliOn name, from August 1 to October 8, 2008.
FDA is urging healthcare professionals and patients to check their supplies of U-100 insulin syringes for the recalled products and not use them. The recalled syringes can be returned to Wal-Mart or Sam's Club for replacement.
FDA Patient Safety News: Jan/Feb 2009
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=83#2
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