Disetronic Medical Systems Recalls ACCU-CHEK Ultraflex Infusion Sets
Disetronic Medical Systems, Inc, announced today a voluntary nationwide recall of all ACCU-CHEK Ultraflex infusion sets, because a tubing could fully or partially separate at the luer lock-tubing connection. In the event that such a thing occurs, insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can lead to hyperglycemia. Symptoms include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain.
Under this recall, customers have the option of continuing to use their ACCU-CHEK 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-CHEK 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.
More details in this press release.
April 3, 2006 Related topics: Product Recalls