A Medical Device Daily
Disetronic Medical Systems (Fishers, Indiana) reported 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. This recall applies to all of the sets, the company said.
Disetronic said that in the event that a full or partial separation occurs, it is possible that insulin could leak from the tubing and cause interruption of insulin delivery, which can cause hyperglycemia.
Patients using any standard luer-lock insulin pump may also be using these Accu-Chek Ultraflex infusion sets. The company said it is advising customers to check their infusion sets at the luer lock-tubing connection at least every three hours and before bedtime.
Under this recall, customers have the option of continuing to use the product or receiving replacement infusion sets for any products exhibiting full or partial separation of the luer lock-tubing connection.
The company said the replacement devices may still experience this full or partial separation of the luer lock-tubing connection.
Customers also have the option of replacing their current infusion sets with Accu-Chek Tender, or Accu-Chek Rapid-D infusion sets.
The company said the recall responds to a recent increase in complaints regarding fully or partially separated luer lock-tubing connections.
Sarah Hanssen, vice president of Disetronic, said, “We are working with the FDA to ensure the proper notification of patients and healthcare providers.“
In another warning, the FDA is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems, manufactured by Valeant Pharmaceuticals (Costa Mesa, California).
The company said there have been more than 100 reports of cracked applicator tips in the 10 mg and 20 mg syringes, the frequency varying, but as many as 6% of syringes in some lots showing the cracks. It said the cracks can result in the leakage of gel during its application, which results in the patient not getting enough medicine to control seizures.
Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or care givers at home.
“FDA is working with the manufacturer to resolve this issue as quickly as possible, as this is the only product approved to treat patients with this condition at home,“ said Dr. Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research. “However, with routine inspection of the product, patients will be able to get the correct dosage administered for treatment.“