This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or through the blood vessels (intravenous). It uses a luer-compatible syringe for the treatment of excess potassium in the blood (acute hyperkalemia).
Cardinal Health recalled three lots of the packs due to an incompatibility with needleless IV connectors. If someone uses the affected device 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. This occurs due to the fact that not all the medication will leave the syringe.
Using the affected product may cause serious adverse health consequences. That could include high (hyperglycemia) or low (hypoglycemia) blood sugar, fat breaking down too fast in the body (diabetic ketoacidosis) and death.
Cardinal Health reports no injuries or deaths related to the issue.
The FDA’s notice says customers should not use syringes from the affected product code and lot numbers to administer IV push insulin using a needleless connector. Cardinal Health issued an Urgent Medical Device Recall letter in September. It said all users of the affected product should not use it to administer IV push insulin using a needleless connector.
