Archived - Important Safety Information on the recall of Accu-Chek Ultraflex Infusion Sets -Disetronic Medical Systems, In

In the course of normal daily use, ACCU-CHEK Ultraflex Infusion Sets can bend at the luer lock-tubing connection. This bending can lead to full or partial separation 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 and has contributed to hyperglycemia. We are taking this action because we have recently received an increase in complaints regarding fully or partially separated luer lock-tubing connections with ACCU-CHEK Ultraflex infusion sets. We are conducting an ongoing investigation into these issues and will update you as new information becomes available.