FDAnews Device Daily Bulletin

FDA, BOCA MEDICAL ISSUE NOTICE OF RECALL EXTENSION FOR INSULIN SYRINGES

May 25, 2006
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The FDA May 23 announced an extension of Boca Medical Products' recall of two types of insulin syringes to treat diabetes.

The company May 19 issued its original recall for Ultilet and Closercare insulin syringes because of bacterial contamination with paenibacillus. The bacteria present a risk of local infection due to soft tissue injection with a contaminated syringe, as well as a risk of introducing contaminating organisms into a previously sterile vial, the company said.

The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels, the firm added.

To view the recall notice, go to http://www.fda.gov/medwatch/safety/2006/closercare_recall.htm (http://www.fda.gov/medwatch/safety/2006/closercare_recall.htm).