Cardinal Health Latest News

02/02/2024

In close coordination with the U.S. Food and Drug Administration (FDA), Cardinal Health today 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.  

This product removal supersedes our previous communications dated September 20, 2023, and December 28, 2023, both related to the Cardinal Health brand Monoject™ sterile syringes’ pump compatibility due to a change in manufacturing and rebranding efforts. It is our intention that expanding the recall action from a product correction to a product removal of all Cardinal Health brand Monoject™ sterile syringes outlined below will reduce confusion and create a simplified course of action for our customers as we continue to work with the FDA, the syringe manufacturer and pump manufacturers to reintroduce Cardinal Health brand Monoject™ sterile syringes.   

Our goal, always, is to provide safe, high-quality products. We understand the critical role our products play in providing safe, effective patient care, and we are committed to getting this right in collaboration with pump manufacturers.  

Customers who received the listed lots were given instructions to:    

1. REVIEW inventory for the affected product codes and lots. Location of product code and lot are shown in below listed table.  

2. COMMUNICATE with all personnel that utilize the Cardinal Health brand Monoject™ Luer-Lock Tip 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, that they should not be used.    

3. SEGREGATE and quarantine all affected product upon review of inventory. Product should not be used and cease using the product immediately. Utilize provided return directions to return product.   

4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected syringes.  

5. DISTRIBUTORS TO NOTIFY any customers to whom they may have distributed/forwarded affected product to or will send the product on to about this medical device product recall and share a copy of this notice.  

6. RETURN the provided acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether they have affected product or not.  

For additional questions related to this recall, customers should reach out to: fieldcorrectiveaction@cardinalhealth.com or call 800-292-9332.  

Impacted Product Code and Lot Information 

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