BD Alaris Infusion Pump Recall Linked to Problems with Monoject Syringes

Becton Dickinson (BD) is recalling its Alaris syringe and patient-controlled analgesia (PCA) pain management pumps, because they may be incompatible with the new dimensions of Cardinal Health Monoject syringes, which have been linked to problems fitting with similar devices.

The U.S. Food and Drug Administration (FDA) announced the Alaris infusion pump recall on December 1, indicating that the Monoject syringes most commonly used with the pumps may not properly administer medications to patients, which can result in potentially serious adverse health outcomes for patients.

Alaris pumps deliver medications and other fluids to patients using specific syringes, including Cardinal Health Monoject syringes, which were recently rebranded from Covidien Monoject syringes. The 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 recently changed following the rebrand, potentially causing certain Alaris syringe and PCA pumps to not recognize the syringe. As a result, the device to refuse to operate, or dispense the wrong amount of medication.

While no deaths have been reported in relation to the incompatibility problems, officials have become aware of at least 13 injuries to date, which involved medication overdoses or underdoses, delayed blockage alarms, and other performance issues.

Monoject Syringe and PCA Pump Compatibility Warning

Monoject syringes are loaded directly into infusion pumps to inject or withdraw medications and other fluids into or from the body.

The FDA issued a Cardinal Health Monoject Syringe warning on November 20, urging consumers to not use them with PCA pumps, due to a risk that they may not fit properly and be incompatible with the devices.

Officials released the warning after receiving at least 15 consumer complaints, involving delayed therapy due to the pumps failing to recognize the syringes, and at least 13 reports involving the pumps dispensing inaccurate amounts of medications or fluids, which resulted in several injuries.

FDA Monoject Syringe Problem Investigation

The FDA has been investigating problems with Cardinal Health Monoject syringes failing to connect to PCA pumps since September, following a syringe recall that impacted more than 32 million syringes with Luer-lock tips.

The recall was issued after the syringes were found to be incompatible with the pumps and failed to deliver the correct amount of fluids.

Officials are currently working with the manufacturer to address the compatibility problems, and indicate that consumers can continue using the older Covidien Monoject syringes with the syringe or PCA pumps. They also noted that both products are branded with the same Monoject indicator, and can only be distinguished from each other using the outer packaging.

Alaris Infusion Pump Recall

The infusion pump recall impacts approximately 220,120 Alaris syringe pump and PCA modules, as well as approximately 867,362 PCU modules distributed between June 19, 2004 and September 22, 2023. The recall was conducted as a product correction, not as a product removal.

For more information, consumers may contact BD Support Center by phone at 888-562-6018.

The FDA also encourages patients and health care professionals to report any problems or side effects experienced with use of the recalled Alaris pumps to the FDA MedWatch Adverse Event Reporting Program.