Cardinal Health earns FDA Class I tag for warning against certain uses of Monoject syringes

The FDA has doled out its most serious classification to a recall of some Cardinal Health medical supplies.

In this case, the recall doesn’t describe a product removal, but merely a correction to the affected devices’ usage instructions, after Cardinal Health discovered that certain batches of its Monoject syringes are incompatible with syringe pumps.

According to a Tuesday notice from the FDA—in which it handed down its Class I categorization—the recall covers more than 32.4 million syringes distributed in the U.S. between June and August of this year. They’re all luer-lock tip Monoject syringes, with sizes ranging from one to 60 milliliters.

Previous iterations of the syringes—which were formerly sold with Covidien branding, before Cardinal Health acquired some of Covidien’s medical supplies from Medtronic several years ago—were able to be used with syringe pumps, used to deliver medications, blood and other fluids in smaller quantities than infusion pumps.

Beginning with the June lots, however, the Cardinal-branded syringes were fashioned with slightly different dimensions to their Covidien forebears, making them incompatible with the pumps.

That means using one of the affected syringes with a syringe pump could potentially impede its performance, resulting in an overdose or underdose, delays in therapy, or delays in occlusion alarms, according to the FDA.

To date, according to the notice, Cardinal Health has received reports describing 15 cases where a syringe pump didn’t recognize a Monoject syringe, delaying therapy, plus another 13 reports of inaccurate medication dispensing, some of which led to patient injuries. The company said it has not received any reports of patient deaths.

In a notice sent to affected customers in September, Cardinal requested that they identify all syringes in their inventory that are affected by the recall and inform anyone who may use the syringes that they shouldn’t be used with syringe pumps. The Covidien-branded versions, meanwhile, may still safely be used.

This isn’t the first time Cardinal’s Monoject products have found themselves in the FDA’s crosshairs.

In 2021, the devicemaker began a recall of around 267 million Monoject syringes prefilled with saline solution. Some of the devices were found to have flawed plunger mechanisms that could cause the plunger to pull back after excess air had already been expelled, potentially bringing air back into the syringe that, if injected into a patient’s bloodstream, could create a life-threatening air embolism.

Because of that risk, the FDA once again handed down a Class I label to the recall. Cardinal said in its initial recall notice that it had received 37 complaints about the plunger issue, with no reports of injuries or death.