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Date Issued: February 2, 2024

The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use certain Cardinal Health Monoject luer-lock and enteral syringes.

On February 2, 2024, Cardinal Health announced a recall for removal of all sizes of the following Cardinal Health brand Monoject syringes:

• Cardinal Health Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35, and 60 mL) and
• Cardinal Health Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL), which are color-coded purple to denote enteral feeding only.

While these Cardinal Health brand Monoject syringes should not be used, Covidien brand Monoject syringes are NOT included in this recall.

Recommendations for Consumers, Health Care Providers, and Facilities

• Review the Urgent Medical Device Product Recall notice from Cardinal Health for removal of certain Cardinal Health Monoject syringes, which includes product numbers and Unique Device Identifier (UDI) information.
• Do not use Cardinal Health Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35 and 60 mL).
• Do not use Cardinal Health Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL), which are color-coded purple.
• Covidien brand Monoject syringes are not included in this recall.
• If you have questions about this recall, contact Cardinal Health Customer Service group by phone, Monday through Friday, between 8:00 a.m. and 5:00 p.m. (EST):
  • Hospital: 800-965-5227
  • Federal Government: 800-444-1166
  • Distributor: 800-635-6021
  • All Other Customers: 888-444-5440

Or contact the Cardinal Health market action team by email at: GMB-FieldCorrectiveAction@cardinalhealth.com.

• Report any issues with syringes to the FDA.

Device Description

Cardinal Health Monoject luer-lock disposable syringes are used to inject fluid into or withdraw fluids from the body. When used with syringe pumps and patient-controlled analgesia (PCA) pumps, these syringes are loaded with fluid or medications and placed into the pump.

Cardinal Health Monoject enteral syringes are used to deliver fluid, feeding, or medications to a patient’s feeding tube (enteral tube). When used with enteral syringe feeding pumps, these syringes are loaded with fluid, feeding, or medications and placed into the pump.

Issues with Certain Cardinal Health Monoject Syringes

In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health” Monoject syringes. These new syringes differ from the previously branded “Covidien” Monoject syringes as they have different dimensions and are made by a different contract manufacturer.

The dimensional changes made to the Cardinal Health Monoject syringes, when used with syringe pumps, PCA pumps, or enteral syringe pumps, may result in recognition, compatibility, and pump performance issues, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding.

For any syringe, there is the potential that changes to dimensions could affect the performance of the device when used alone or with pumps.

FDA Actions

The FDA will continue to work with Cardinal Health to help ensure that the public is notified to stop using the recalled products.

The FDA is monitoring reports of problems with syringes and will continue to keep the public informed if new or additional information becomes available.

A timeline and summary of the FDA’s previous communications related to these devices is provided below.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

Reporting Problems to the FDA

If you think you had a problem with a syringe, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

If you are experiencing supply issues for syringes, or other devices, you may contact the FDA about a medical device supply chain issue. Reporting supply chain issues to the FDA helps inform actions to prevent shortages and protect patient health.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.