FDA Warns “Do Not Use” Cardinal Health Monoject Syringes With Syringe Pumps and PCA Pumps

Warning comes after Cardinal Health recalled more than 32 million syringes in September, because they may not fit correctly into certain pain management drug pumps.

Doctors and healthcare facilities are being urged not to use Cardinal Health Monoject syringes with patient-controlled analgesia (PCA) pain management pumps, because they may be incompatible and not fit properly.

The U.S. Food and Drug Administration (FDA) issued the Cardinal Health Monoject syringe “Do Not Use” warning on November 20, due to a risk that use of the Monoject syringes with certain pain management pumps may cause the medications to not be administered properly, leading to potentially serious side effects for patients.

While the agency continues to evaluate the problems, doctors are being told to avoid using the syringes in combination with the PCA pumps.

Monoject Syringe and PCA Pump Compatibility Problems

Monoject syringes are used to inject and withdraw medications and fluids into or from the body. This can include administering fluids like blood or painkillers. When used with PCA pain pumps, the syringes are loaded with fluid or medications and placed directly into the pump.

In June 2023, Cardinal Health began distributing new Monoject syringes, replacing those original sold under the Covidien brand name. However, the new syringes have different dimensions, which has been linked to problems connecting them with PCA pain pumps.

If the syringe does not fit the pump properly, the device may have problems recognizing the syringes. This can lead to overdose, underdose, delays in therapy, delays in alarms, compatibility issues, and performance issues.

The FDA has received at least 15 reports of delayed therapy because of PCA pumps not recognizing the syringes and 13 reports of inaccurate dispensing, which also involved injuries. There were no reports of patient deaths.

In September, Cardinal Health issued a Monoject syringe recall for those devices with Luer-lock tips. The recall, which affected more than 32 million syringes, was given a Class I recall designation, after the FDA determined they posed a serious injury or death risk to users. The recall was conducted as a product correction, not as a product removal.

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FDA Continues to Investigate Monoject Problems

The FDA indicated the compatibility issues will be investigated further to find out if the issues affect other brands or other sizes of Monoject syringes. The FDA is working with the manufacturer to address the concerns.

The agency notes that facilities can continue using the older Covidien Monoject syringes with syringe pumps or PCA pumps, but it is important to note both brands of syringes have the “monoject” indicator on the syringe and do not include the company name. Only the outer packaging contains the Covidien brand name and will indicate if it is for a PCA pump.

FDA officials encourages patients and health care professionals to report problems and side effects experienced with the use of Cardinal Health Monoject syringes to the FDA’s MedWatch Adverse Event Reporting Program.

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