Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing

UPDATE: March 7, 2024

Cardinal Health is expanding their previous product correction actions to a product removal. The devices described in this recall are included in the Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication on February 2, 2024.

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:
  • Cardinal Health Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35, and 60 mL)
  • 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.
• Product Codes: FMF, PNR
• Lot Numbers: See Recall Database Entries
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
• Distribution Dates:
  • Luer Lock: June 1, 2023 to August 31, 2023
  • Enteral Syringes: September 1, 2023 to October 10, 2023
• Devices Recalled in the U.S.:
  • Luer Lock: 26,973,040
  • Enteral Syringes: 701,678
• Date Initiated by Firm: December 28, 2023

Device Use

Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw fluids from the body. When used with syringe pumps, the Monoject disposable 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.

Syringe pumps deliver solutions such as fluids, medications, and blood products to patients.

Reason for Recall

Cardinal Health is expanding their previous product correction actions to a product removal of Cardinal Health brand Monoject sterile Luer-Lock Soft Pack Syringes (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

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.

There have been no reports of death.

Who May be Affected

• People who receive care with Cardinal Health sterile Monoject Luer-Lock and Enteral Syringes.
• Health care providers who use Cardinal Health sterile Monoject Luer-Lock and Enteral Syringes.

What to Do

On February 2, 2024, Cardinal Health sent all affected customers an URGENT medical device product removal letter regarding the sterile Enteral Syringes and the Luer Lock syringes.

The letter requested customers to:

• Review inventory for the affected product codes and lots and to not use them.
• Communicate with all personnel who use affected product.
• Notify any customers to whom affected products may have been distributed/forwarded to and share a copy of the notice.
• Segregate and quarantine all affected product. Utilize the return directions provided in the letter.
• Complete and return the acknowledgement form included in the letter.

Contact Information

Customers in the U.S. with questions about this recall should contact the Cardinal Health market action team at 1-800-292-9332 or email GMB-FieldCorrectiveAction@cardinalhealth.com.

Additional Resources:

• Medical Device Recall Database Entries
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
  • Class 1 Device Recall Cardinal Health Monoject (fda.gov)
• Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication
• Voluntary Recall Announcement for Cardinal Health Brand MonojectTM Sterile Syringes

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.