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Boca Medical Products, Inc. (Coral Springs, FL) has initiated a recall of 3984 boxes of its 30-g, 0.5-cc "Ultilet" insulin syringe.
Boca Medical Products, Inc. (Coral Springs, FL, www.bocamedicalproducts.com) has initiated a recall of 3984 boxes of its 30-g, 0.5-cc "Ultilet" insulin syringe. The recalled product lot number is 5GEXI, which is displayed on the product's inner case. The syringes are being recalled because of the possible presence of Bacillus cereus and Staphylococcus intermedius bacteria. The contamination may degrade the insulin, which could make it difficult for patients to maintain their insulin levels. Soft-tissue injection with a contaminated syringe also presents the risks of local infection and introducing a contaminating organism into a previously sterile vial.
Boca began an investigation after receiving a single complaint and an event report. According to the complaint, the insulin solution changed color when entering the syringe chamber. No serious injury has been reported, and no other lot is included in the recall. The firm's decision to recall the product lot is voluntary, and it informed the US Food and Drug Administration (Rockville MD, www.fda.gov) of its action.