February 5, 2024- In close coordination with the U.S. Food and Drug Administration (FDA), Cardinal Health issued a voluntary product removal of all sizes of Cardinal Health brand Monoject™ Luer-Lock Soft Pack Sterile Syringes (1, 3, 6, 12, 20, 35 and 60 mL) and Cardinal Health brand Monoject™ Enteral Sterile Syringes with the ENFit™ connection (1, 3, 6, 12, 35 and 60 mL), which are color-coded purple to denote enteral feeding only.
This product removal is lot-specific and applies to all Cardinal Health brand Monoject™ sterile syringes outlined below. Covidien brand Monoject™ syringes of all sizes are not impacted by this product action. Customers that purchase Presource custom kits with impacted components will be notified through a separate letter of this product removal.
If used with a pump, the Cardinal Health brand Monoject™ sterile syringe may not be recognized by the pump and may result in delay of treatment or therapy. Conversely, if the syringe is recognized by pumps, it may result in volume and/or infusion rate discrepancies, which can lead to over- or under-infusion. While we have not received any reports of patient death for impacted syringes, there is a potential risk of serious injury or death.