Cardinal Health Monoject Syringe Recall Issued Over Problems Fitting Drug Pumps

The FDA first warned of problems with Cardinal Health Monoject syringes failing to fit drug pumps in November 2023.

A recall has been issued to remove all sizes of Cardinal Health brand Monoject Luer-Lock and Enteral Syringes from the market, because they may be incompatible with feeding and patient-controlled analgesia (PCA) pain management pumps.

The U.S. Food and Drug Administration (FDA) announced the Cardinal Health Monoject syringe recall on February 2, indicating the new dimensions of the syringes may not fit properly with certain medical pumps, which can cause the devices to improperly administer medications or nutrition.

Cardinal Health Monoject luer-lock disposable syringes are used to inject or withdraw fluids and medications, which are designed to be used with a syringe or PCA pump. The Monoject enteral syringes deliver fluids, medications, and feeding nutrition to a patient’s enteral tube, or feeding tube, and are designed to be used with enteral syringe feeding pumps. Certain devices have pre-programmed syringe dimensions that are used to determine how much medication is in the syringe, based on information about the brand from its compatible syringe library.

Officials indicate the dimensions of the Cardinal Health Monoject syringes changed in June 2023, after the company rebranded “Covidien” brand Monoject syringes and started using a different product manufacturer. As a result of the dimensional and manufacturing changes, medical pumps may not recognize the syringes and refuse to operate, or dispense the wrong amount of fluid or medication.

Monoject Syringe Warning

The FDA issued a Cardinal Health Monoject Syringe warning in November 2023, urging consumers and health care professionals to avoid using them with PCA pumps, due to a risk that they may not fit and could be incompatible with the devices.

Officials released the warning after at least 15 complaints of infusion pumps failing to recognize the syringes, resulting in delayed therapy. The FDA also received at least 13 other complaints involving inaccurate medication dispensing, which resulted in an undisclosed number of injuries.

An Alaris infusion pump recall was issued in December 2023, after at least 13 injuries were reported in relation to the incompatibility problems. The pumps were most commonly used with Monoject syringes, and used pre-programmed syringe dimensions that determined how much medication was in the syringe.

Cardinal Health initially issued a previous  Monoject syringe recall in September 2023, which affected more than 32 million syringes. However, the recall was conducted as a product correction and not as a product removal.

Cardinal Health Monoject Recall

This latest recall, now being conducted as a product removal, impacts all sizes of Cardinal Health Monoject Syringe Luer-Lock Tip Soft Packs and Monoject Enteral Syringes with ENFit connection, which are color-coded purple to indicate they are only for enteral feeding use. The syringes were distributed from June 1, 2023 until August 31, 2023.

Covidien branded Monoject syringes are not affected by the recall and may still be used with syringe and PCA pumps, the recall notice indicates.

Consumers may visit the FDA or manufacturer’s recall notice to view the full list of products, product codes, and lot numbers impacted by the recall.

For more information, consumers may contact Cardinal Health customer service by phone at 888-444-5440, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EST. They may also email Cardinal Health market action team at GMB-FieldCorrectiveAction@cardinalhealth.com.

The FDA also encourages patients and medical professionals to report any adverse reactions or quality problems they experienced while using the Cardinal Health Monoject syringes to the MedWatch Adverse Event Reporting Program.