April 13, 2006 — /FDA News/ — Coral Springs, Fla. — 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. Send the product to Boca Medical Products Inc, 3550 NW 126 th Ave, Corals Springs, FL 33065. Attention: Recall Contact. For any question related to the case consumers should call 1-800-354-8460.
The recall include the following product:
Product Description – Ultilet Insulin Syringe 30g 1/2 cc
Lot – 5GEXI
NDC # – 08326-3002-50
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.
No serious injury has been reported. No other lot is included on this Recall.
Boca Medical method of distribution is through wholesalers. This product is sold by prescription orders. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.
Boca Medical is notifying its wholesalers by fax and is arranging for the return of the recalled product from retail and consumer level.
Consumers with questions including physicians and pharmacists may contact Boca Medical at 1-800-354-8460.