Recall Notice: Boca Medical Ultilet and Closercare Insulin Syringes
The following information is from Boca Medical Products, Inc. Contact the company for a copy of any referenced enclosures.
For Immediate Release
Company Contact: Recall Representative
Company Phone: 1-800-354-8460
Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 41 boxes of Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and 2320 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5KEO1 as displayed on the inner case. The products are being recalled because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Previous recalled lot was 5GEX1.
Consumers who have product lots 5JCZ1 and 5KEO1, should stop usage and return the specific products. Wholesalers should stop retail and return the product lots. 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 includes the following products:
Product Description - Closercare Insulin Syringe 29g 1 cc
Lot - 5JCZ1
NDC # - 08464-1029-01
Product Description - Ultilet Insulin Syringe 30g ½ cc
Lot - 5KEO1
NDC # - 08326-3002-50
No complaint has been reported related to these lots. The firm decision to recall the product lots is voluntary. The firm is performing sterility test on all lots received by the contract manufacturer. FDA has been apprised of this action.
No injury of any kind has been reported.
Boca Medical is a private label distributor and the method of distribution is through wholesalers. This product is sold by prescription orders. These products have been distributed to the following states: FL, NY, AL, SC, NC, CO, TX, VA, AZ, KY, MS, OH.
Boca Medical is notifying its wholesalers by fax and is arranging for the return of the recalled product. Consumers with questions may contact Boca Medical at 1-800-354-8460.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.