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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Disetronic Medical Systems, Inc. Announces a Voluntary Nationwide Recall Of All ACCU-CHEK  Ultraflex Infusion Sets

Contact:
Joel Reuter
317-521-7431

FOR IMMEDIATE RELEASE -- Fishers, IN -- April 3, 2006 -- Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind. announced today a voluntary nationwide recall of all ACCU-CHEK Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient's healthcare team and follow the medical advice given by the healthcare professional or contact their physician.

This recall applies to all ACCU-CHEK Ultraflex infusion sets. Patients using any standard luer-lock insulin pump may also be using these ACCU-CHEK Ultraflex infusion sets. Disetronic is advising customers to check their infusion sets at the luer lock-tubing connection at least every 3 hours and before bedtime.

Under this recall, customers have the option of continuing to use their ACCU-CHEKT Ultraflex infusion set, and receiving replacement ACCU-CHEK Ultraflex infusion sets for any products exhibiting full or partial separation of the luer lock-tubing connection. Customers deciding to continue using the ACCU-CHEK Ultraflex or a replacement ACCU-CHEKT Ultraflex infusion set, must check their infusion set at the luer lock-tubing connection during use at least every 3 hours and before bedtime.   The replacement ACCU-CHEK Ultraflex infusion sets may still experience this full or partial separation of the luer lock-tubing connection.

Customers also have the option of replacing their ACCU-CHEKT Ultraflex infusion sets with ACCU-CHEKT Tender, or ACCU-CHEKT Rapid-D infusion sets.

Customers that have fully or partially separated tubing sets, or wish to discontinue use of their ACCU-CHEK Ultraflex Infusion Set may call Disetronic Medical Systems Pump Support at 1-800-688-4578 for replacement. If you do experience product problems, you should contact Disetronic, for a pre-paid mailer in order to send the affected infusion set back to Disetronic for analysis.

Disetronic is conducting this recall of ACCU-CHEK Ultraflex infusion sets now, because of a recent increase in complaints regarding fully or partially separated luer lock-tubing connections. Disetronic has an ongoing investigation into these issues and will update our customers, their healthcare providers and our distributors as new information becomes available. If you are a physician or a patient who has experienced a problem with any ACCU-CHEK Infusion Sets, please notify Disetronic at 1-800-688-4578.

Infusion set customers who purchased the ACCU-CHEK Ultraflex Infusion sets should always follow labeling instructions for proper use. In addition, healthcare officials suggest that diabetes patients who are on insulin pump therapy should check their blood glucose levels 1-3 hours after changing the infusion set systems, and continue to check throughout the day as instructed by their healthcare provider.

In the course of normal daily use, infusion sets can be subjected to a variety of stresses, including bending at the luer lock-tubing connection, which can lead to full or partial separation at the luer lock-tubing connection. Therefore, the potential for separation of the luer lock-tubing connection still exists with the replacement ACCU-CHEK Ultraflex infusion set. Information and illustrations that depict the luer lock-tubing connection can be found on Disetronic's website at www.disetronic-usa.com.

ACCU-CHEKT Ultraflex Infusion Sets are available by prescription only for diabetes patients who use insulin pump therapy. The firm is notifying by direct mail affected customers, healthcare providers and its distributors of this action.

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.

"After learning about this problem and our records of complaints, we decided to voluntarily notify patients, healthcare providers and distributors regarding this product. We care about patient safety, their well being and peace of mind and will be pleased to work with anyone who desires a replacement of their ACCU-CHEKT Ultraflex infusion set." said Sarah Hanssen, Vice President of Disetronic Medical Systems. "We are working with the FDA to ensure the proper notification of patients and healthcare providers."

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