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

• Monoject Flush Prefilled Syringes (0.9% sodium chloride)
• Product Codes, All Lots:
  • Product Code (SKU) - Product Description:
    • 8881570121 - 12mL Syringe, 10mL Saline Fill
    • 8881570123 - 12mL Syringe, 3mL Saline Fill
    • 8881570125 - 12mL Syringe, 5mL Saline Fill
• Distribution Dates: July 1, 2019 to July 1, 2021
• Devices Recalled in the United States: 267,217,860
• Date Initiated by Firm: August 4, 2021

Device Use

Monoject Saline Flush Prefilled Syringes are used to flush out many different types of intravenous (IV) tubing and other devices that give health care workers access to the blood vessels (intravascular access devices) for fluid and medication delivery. These syringes are prefilled with preservative-free saline in various sizes and different amounts of saline (volumes). They are disposable and used one time only.

Reason for Recall

Cardinal Health is recalling three models of Monoject Saline Flush Prefilled Syringes because it is possible the syringe’s plunger may pull air into the syringe after the health care provider has pushed out (expelled) the air. The materials used to make the syringe let the plunger slip back in the syringe. If air is injected into blood vessels, it can block the vessel (air embolism). Air embolisms can result in serious adverse health consequences, including stroke or death.

There have been 37 complaints, no injuries, and no deaths reported for this issue.

Who May be Affected

• Health care providers using Monoject Saline Flush Prefilled Syringes
• Patients who require care using Monoject Saline Flush Prefilled Syringes

What to Do

On August 4, 2021, Cardinal Health issued an Urgent Medical Device Recall letter to customers with the following instructions:

• Review inventory for the affected product.
• Separate the affected product on-hand from other products.
• Share this information with clinical staff through safety huddles to ensure awareness.
• Return an acknowledgement form provided with the letter, whether or not there is affected product in the facility.
• Contact the appropriate customer service group to arrange for return and credit of affected product, if product was received directly from Cardinal Health.
  • Hospital customers: 800-964-5227
  • Federal government customers: 800-444-1166
  • Distributors: 800-635-6021
  • All other customers: 888-444-5440
• Contact the location where these products were purchased if they were not purchased directly from Cardinal Health.

Contact Information

Contact the Customer Service group with any questions about the recall:.

• Hospital customers: 800-964-5227
• Federal government customers: 800-444-1166
• Distributors: 800-635-6021
• All other customers: 888-444-5440

Additional Resources:

• Cardinal Health Urgent Medical Device Recall Notice
• Medical Device Recall Database Entry

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.