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April 13th: Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product

Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius. This present a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organism into previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Boca Medical continues to evaluate possible risks.

Consumers who have Ultilet Syringe Insulin product lot 5GEXI, should stop usage and return the specific product. Wholesalers should stop retail and return the product lot.

A single complaint and a reported event prompted a Company investigation, which is on going. The compliant stated that when the syringe was used, the color of the insulin solution entering the syringe chamber changed. The firm decision to recall the product lot is voluntary. The firm has placed all inventory of the product on hold. FDA has been apprised of this action. serious injury has been reported. No other lot is included on this Recall.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/oc/po/firmrecalls/bocamedical04_13.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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