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ACCU-CHEK™ Ultraflex Infusion Sets Recalled

April 2006

Diestronic Medical Systems, Inc. announced a voluntary recall of all ACCU-CHEK ™ Ultraflex infusion sets because of a recent increase in complaints regarding fully or partially separated tubing connections.

If a full or partial separation occurs in the tubing, insulin delivery could be affected and lead to hyperglycemia. Symptoms include nausea, vomiting, blurred vision, excessive thirst or hunger, frequent urination, headache, and abdominal pain. Patients experiencing these symptoms are urged to check their blood glucose levels 1-3 hours after changing the infusion set systems and prior to bedtime to ensure their levels are okay.

Customers that have fully or partially separated tubing connections, or who wish to discontinue use may call Disetronic Medical Systems, Inc. at 800-688-4578 for a replacement.

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Source: “Disetronic Medical Systems, Inc. Announces A Voluntary Nationwide Recall Of All ACCU-CHEK ™ Ultraflex Infusion Sets.” FDA Press Release. April 4, 2006.