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Disetronic Medical Systems, Inc. Recall's ACCU-CHEK Ultraflex Infusion Sets
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-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.
Customers also have the option of replacing their ACCU-CHEK™ Ultraflex infusion sets with ACCU-CHEK™ Tender, or ACCU-CHEK 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.
ACCU-CHEK 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.
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