MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Clearlink Basic Solution Set with Duovent by Baxter: Class I Recall – Due to Risk of Leaks That May Expose Providers and Patients to Hazardous/Toxic Substances

Baxter Healthcare Corporation is recalling Clearlink Basic Solution Set with Duovent after increased customer reports of leaks. As the majority of the Clearlink Basic Solution Sets with Duovent are used for the delivery of hazardous drugs (chemotherapy), leakage could expose healthcare personnel, patients and others to these hazardous drugs.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Questions?

Customers with questions or concerns about this recall should contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.