Boca Medical Products recalls Ultilet Insulin Syringe

April 24, 2006

Boca Medical Products and the FDA have notified consumers andhealthcare professionals of a recall of Ultilet Insulin Syringe 30g1/2cc (Lot #-5GEXI; NDC #-08326-3002-50) because ofpossible bacterial presence of Bacillus cereus and Staphylococcusintermedius. This presents a risk of local infection due to softtissue injection with a contaminated syringe as well as a risk ofintroduction of contaminating organisms into a previously sterilevial.

Boca Medical Products and the FDA have notified consumers and healthcare professionals of a recall of Ultilet Insulin Syringe 30g 1/2cc (Lot #-5GEXI; NDC #-08326-3002-50) because of possible bacterial presence of Bacillus cereus and Staphylococcus intermedius. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems for patients maintaining their insulin levels. This product has been distributed to the following states: Alabama, Arkansas, Colorado, Florida, Massachusetts, Mississippi, New York, North Carolina, South Carolina, and Texas. For any questions, consumers should call 1-(800) 354-8460. The safety summary can be found at http://www.fda.gov/medwatch/safety/2006/safety06.htm#boca.

To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.

To go to the Drug Topics homepage, click here http://www.drugtopics.com.