FDA ANNOUNCES CLASSIFICATION OF INFUSION DEVICE RECALL AS CLASS I

The FDA July 21 announced it has classified a recent recall of Disetronic's Accu-Chek Ultraflex-1 infusion set as Class I.

The manufacturer, Indianapolis-based Roche, initiated a recall March 31 for the device, an insulin pump that delivers continuous short-acting or fast-acting U100 insulin to treat diabetes mellitus.

The Class I recall has been issued because the "tubing may fully or partially separate at the luer lock-tubing connection," causing insulin to leak, the FDA said. Such a separation can interrupt insulin delivery and lead to hyperglycemia, the agency added.