FDAnews Device Daily Bulletin


April 18, 2006

Boca Medical Products has issued a recall of 3,984 boxes of its Ultilet Insulin Syringe 30g 1/2cc product lot, number 5GEXI, as displayed on the inner case.

The product is being recalled due to a possible presence of two forms of bacteria that could cause local infection when the syringe is used, the company reported. Bacterial contamination of the syringe could degrade the insulin and cause users to have difficulty maintaining required insulin levels, the company added.

The recall was issued in response to a complaint received by one user who reported that the color of the insulin solution changed when entering the syringe chamber.The product was distributed in Florida, New York, Massachusetts, Alabama, South Carolina, North Carolina, Colorado, Texas, Michigan, and Arkansas. The company has placed all inventory of the product on hold and notified the FDA of the recall, it said.

To learn more, access http://www.fda.gov/oc/po/firmrecalls/bocamedical04_13.html (http://www.fda.gov/oc/po/firmrecalls/bocamedical04_13.html).