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U.S. Department of Health and Human Services

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Boca Medical Ultilet and Closercare Insulin Syringes

Audience: Diabetes healthcare professionals, pharmacists and consumers

[Posted 05/23/2006] Boca Medical Products and FDA notified consumers and healthcare professionals of an extension of an earlier recall of Ultilet Insulin Syringes and the additional recall of Closercare Insulin Syringes because of bacterial contamination with Paenibacillus. 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. The recall includes Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and Ultilet Insulin Syringe 30g 1/2cc, product lot number 5KEO1 as displayed on the inner case. The earlier recall of Ultilet syringes included lot number 5GEXI. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR. 

[May 19, 2006 - Recall Notice - Boca Medical]

Previous MedWatch Alert
[April 17, 2006]