On Feb. 2, 2024 the FDA sent a warning to stop using specific Cardinal Health Monoject luer-lock and enteral syringes. The disposable syringes are used to inject or withdraw fluids into or from the body. The recall is due to recognition, compatibility and pump performance issues, such as overdose, delay in therapy, delay in occlusion alarms, and delay in feeding when the syringes are used with syringe pumps, PCA pumps, or enteral syringe pumps.
Recommended courses: Common Office Procedures
In June 2023, Cardinal Health started distributing Monoject syringes branded as “Cardinal Health Monoject syringes.” The dimensions of these syringes are different than the ones previously branded as “Covidien Monoject syringes” and should not be used with syringe pumps. The dimension changes are causing the performance issues.
While no deaths were reported, Cardinal Health has received 15 reports of delayed therapy as a result of syringe infusion pumps not recognizing syringes. In addition, the company has received 13 reports of inaccurate volume/rate dispensing, including some injuries.
Follow the reporting procedures established by your health facility. If you have supply issues for syringes, you can contact the FDA about medical device supply chain issues.
References
- Food and Drug Administration (FDA) (2024): Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-cardinal-health-monoject-luer-lock-and-enteral-syringes-fda-safety-communication
- Food and Drug Administration (FDA) (2024): Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps. https://www.fda.gov/medical-devices/medical-device-recalls/cardinal-health-recalls-monoject-disposable-syringes-incompatibilities-syringe-pumps#:~:text=Cardinal%20Health%20Recalls%20Monoject%20Disposable%20Syringes%20for%20Incompatibilities%20with%20Syringe%20Pumps,-Share&text=On%20February%202%2C%202024%2C%20Cardinal,luer%2Dlock%20and%20enteral%20syringes.
