FDA Warns Not to Use Cardinal Health Monoject Syringes With Syringe Pumps and PCA Pumps
On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted (https://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-cardinal-health-monoject-syringes-syringe-pumps-and-pca-pumps) healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a Class I recall (https://www.fda.gov/medical-devices/medical-device-recalls/cardinal-health-recalls-monoject-disposable-syringes-incompatibilities-syringe-pumps), the most serious type of recall, where use of the product or device may result in serious injury or death.
In June 2023, Cardinal Health began distributing syringes branded as “Cardinal Health” Monoject syringes. These new syringes differ from the previously branded “Covidien” Monoject syringes in dimension and manufacturer. When used with syringe pumps or PCA pumps, the dimensional changes may result in recognition, compatibility, and pump performance issues such as overdose, underdose, delay in therapy, and delays in occlusion alarms.
On September 20, 2023, Cardinal Health initiated a recall for certain Cardinal Health Monoject single-use Luer-lock tip syringes that informed they should not be used with syringe pumps. The recall is a correction, not a product removal. However, FDA said that it has concerns that the information provided by Cardinal Health has not sufficiently mitigated the risk of incompatibility when Cardinal Health Monoject syringes are used with other pumps, specifically PCA pumps, and that the risk of incompatibility could apply to additional sizes of Cardinal Health Monoject syringes. FDA is working with the manufacturer to address the questions.
Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw fluids from the body. When used with syringe pumps and PCA pumps, disposable syringes are loaded with fluid, medications, or blood products and placed into the pump.
Currently, FDA has received over a dozen reports involving delay in therapy as well as inaccurate therapy (overdose or underdose) associated with the use of Cardinal Health Monoject syringes with a syringe pump or a PCA pump. FDA is not aware of any deaths associated with the issue.
Recommendations for Healthcare Providers
- Do not use Cardinal Health Monoject syringes with syringe pumps or PCA pumps.
- You may continue to use Covidien Monoject syringes with syringe pumps or PCA pumps.
- Be aware that both brands of syringes state only “monoject” on the syringe itself and do not include the company name.
- Keep the outer packaging with the Covidien Monoject syringe prior to using it with a syringe pump or PCA pump for end-users to verify that the syringe can be used.
- Stay alert for further updates and recommendations from FDA or manufacturers.
- Report any problems (https://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-cardinal-health-monoject-syringes-syringe-pumps-and-pca-pumps?utm_medium=email&utm_source=govdelivery#reporting) with Cardinal Health Monoject syringes to FDA.
FDA will continue to work with Cardinal Health and other applicable manufacturers (https://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-cardinal-health-monoject-syringes-syringe-pumps-and-pca-pumps?utm_medium=email&utm_source=govdelivery#other) to further evaluate the issue, monitor reports of adverse events, and identify additional mitigation strategies as needed. It will keep healthcare providers and the public informed if significant, new information or recommendations become available.
Healthcare providers should report any adverse events or suspected adverse events experienced with the Cardinal Health Monoject syringes or any medical device to FDA.
- Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements (https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities) should follow the reporting procedures established by their facilities.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda).
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting regulations (https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities).
For questions about the alert, contact the Division of Industry and Consumer Education (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice).