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Covidien insulin syringe recall

This article was originally published in The Gray Sheet

Executive Summary

Firm's recall of a mislabeled lot of ReliOn sterile, single-use hypodermic syringes with permanently affixed hypodermic needles, initiated Oct. 9, is categorized as Class I by FDA, the agency says Nov. 6. For some packages in lot 813900, syringes labeled for use with U-40 insulin were mixed with syringes labeled for U-100 insulin, which could lead to an up-to-2.5-times overdose, hypoglycemia and other serious health problems or death, FDA says. The recall includes 471,000 individual syringes in 4,710 boxes, sold only at Wal-Mart and Sam's Club pharmacies and distributed from July through Oct. 8. The recalled product can be returned to the stores for replacement
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