Cardinal Health Recalls Monoject Saline Flush Syringes for Air Re-entry Risk

U.S. Food and Drug Administration sent this bulletin at 08/23/2021 02:38 PM EDT

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FDA - Center for Devices and Radiological Health

Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism

Cardinal Health is recalling the Monoject Saline Flush Prefilled Syringes because it is possible the syringe’s plunger may allow air back into the syringe after the health care provider has pushed out (expelled) the air. This could result in injection of air into blood vessels and potential air embolism.

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.

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Questions?

If you have questions about this recall, contact the relevant Cardinal Health customer service group:

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