More insulin syringes recalled

May 30, 2006

Boca Medical Products and the FDA have notified consumers andhealthcare professionals of an extension of an earlier recall ofUltilet insulin syringes and the additional recall of Closercareinsulin syringes because of bacterial contamination withPaenibacillus. 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 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 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 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: Florida, New York, Massachusetts, Alabama, South Carolina, North Carolina, Colorado, Texas, Michigan, and Arizona. Read the complete summary at http://www.fda.gov/medwatch/safety/2006/safety06.htm#closercare/.

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