A Medical Device Daily

Boca Medical Products (Coral Springs, Florida) reported that it has voluntarily recalled 3,984 boxes of Ultilet Insulin Syringe 30g 1/2cc in one product lot.

The recall, it said, is because of the possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius. This, Boca said, presents a risk of local infection due to soft tissue injection with a contaminated syringe, as well as risk of introduction of a contaminating organism into a previously sterile vial.

The complaint stated that when the syringe was used, the color of the insulin solution entering the syringe chamber changed. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.

The company said the product recall was made because of “a single complaint“ and “a reported event“ related to the syringes. It said there has been no report of a serious injury but that it continues to evaluate the possible risks.

The firm has placed all inventory of the product on hold and has notified the FDA concerning the action.

The company said that consumers who have Ultilet Syringe Insulin product lot 5GEXI should stop usage and return the specific product. Wholesalers, it said, should stop retail and return the product lot.

This product, sold by prescription orders, was distributed in 10 states: Florida, New York, Massachusetts, Alabama, South Carolina, North Carolina, Colorado, Texas, Maine and Arizona.

In other recall news:

Following the voluntary recall last week by Bausch & Lomb (Rochester, New York) of its ReNu with MoistureLoc brand contact lens solution, doctors of optometry from the Contact Lens and Cornea Section of the American Optometric Association (St. Louis) issued a statement supporting the decision by the company.

In a statement, it said: “Although a cause has not been officially determined, health officials from the federal government are investigating reports that fusarium keratitis, a severe corneal fungal infection, has been potentially linked to the ReNu with MoistureLoc brand contact lens solution.“