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U.S. Department of Health and Human Services

Safety

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Boca Medical Ultilet Insulin Syringe 30g 1/2cc

Audience: Diabetes healthcare professionals, pharmacists and consumers

[Posted 04/17/2006] Boca Medical Products and FDA 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 a risk of introduction of contaminating organisms into a previously sterile vial.  The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.  For any question related to the case consumers should call 1-800-354-8460.

[April 13, 2006 - Press Release - Boca Medical]