Boca Issues Nationwide Recall of Ultilet Insulin Syringe

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, due to possible bacterial presence.

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 ½ cc
Lot – 5GEXI
NDC # - 08326-3002-50

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.

Source: FDA

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