The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module
• Model Numbers: 8110, 8015, 8120
• Distribution Dates: June 19, 2004 to September 22, 2023
• Devices Recalled in the U.S.: 220,120 syringe pump and PCA modules and 867,362 PCU modules
• Date Initiated by Firm: September 15, 2023

Device Use

The Alaris infusion pump is a modular infusion pump system generally intended to deliver medications or other fluids. The syringe and PCA pump modules are validated for use with specific syringes, as reflected in the product labeling. On the Alaris system, the user enters the nominal volume of the syringe and selects the syringe brand from a library of compatible syringes. This instructs the PCU on which pre-loaded syringe dimensions to use when calculating the volume of fluid in the syringe.

Monoject is one of the most common syringes used with infusion pumps and is specifically mentioned as an example in the Alaris 8015 user manual as shown below.

Reason for Recall

Becton Dickinson (BD)/Carefusion 303 is recalling their Alaris Infusion Pumps to update the labeling due to compatibility issues with Cardinal Health Monoject syringes.

The Alaris pumps are validated for use with ‘Monoject’ syringes and list ‘Monoject’ as one of the options when the user is selecting a syringe type within the Alaris system. However, the dimensions for Monoject syringes have recently changed while rebranding the syringes from “Covidien Monoject” to “Cardinal Health Monoject.” Cardinal Health branded Monoject syringes have not been validated for use with the BD Alaris Syringe and PCA modules. When one of these new syringes is used with the previous syringe settings, the pump may either refuse to operate or incorrectly estimate the volume of liquid in the syringe. This has resulted in over and under infusions, as well as delays in therapy.

Use of incompatible syringe sizes and models with the BD Alaris Syringe and PCA Modules can impact syringe pump operation resulting in inaccurate fluid delivery, delayed generation of occlusion alarms, and other potential problems.

There have been 13 reported injuries. There have been no reports of death.

Who May be Affected

• Health care providers using the affected Alaris Pump System with Cardinal Health Monoject syringes
• Patients who receive fluids or medications delivered by the affected Alaris Pump systems with Cardinal Health Monoject syringes

What to Do

On September 15, 2023, Becton Dickinson (BD) sent all affected customers an Urgent Medical Device Labeling Correction.

The letter requested customers to:

• Stop use of Cardinal Health branded Monoject syringes with the BD Alaris Syringe and PCA Modules.
• Replace the current BD Alaris Syringe and PCA Module Compatibility Lists with the updated compatibility lists attached to the letter.
• Complete the Customer Response Form that was attached to the letter and return to the BD contact noted on the form to acknowledge receipt of this notification.

Contact Information

Customers in the U.S. with questions about this recall should contact BD Support Center at 888-562-6018.

Additional Resources:

• Medical Device Recall Database Entry - 8110
• Medical Device Recall Database Entry - 8015
• Medical Device Recall Database Entry - 8120
• Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.