FDA designates Class 1 recall for insulin syringes

Editor's Note

The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death.

The product is designed to administer insulin subcutaneously or intravenously, using a luer-compatible syringe for treatment of acute hyperkalemia. According to FDA’s December 4 announcement, the recall was motivated by an incompatibility with needleless IV connectors. “If the affected device is used to administer IV push insulin through a needleless connector, it may increase the risk that the patient may not receive the full dose of insulin because not all the medication will leave the syringe.”

Risks include hyperglycemia, hypoglycemia, diabetic ketoacidosis, and death. No injuries or deaths have been reported.

The full FDA report offers more comprehensive information, including specific lot numbers of affected syringes.