FDA Class I Recall: Alaris Syringe and Alaris PCA Modules by BD CareFusion 303

Sept. 18, 2020

BD/CareFusion 303 is recalling the Alaris Syringe and Alaris PCA Modules due to Alaris PC units may display the incorrect syringe types and/or sizes, announced the U.S. Food and Drug Administration (FDA) in a press release. This could potentially result in delays in infusion, under-infusion, or over-infusion leading to serious adverse events, including death.

There have been no reported injuries or deaths. 

Recalled Products: 

·       BD Alaris Syringe Module; and BD Alaris PCA Module, Syringe/PCA Sizer Sensor Replacement Kit

·        Module Number:

·        BD Alaris Syringe Module Model 8110

·        BD Alaris PCA Module Model 8120

·        BD Alaris Syringe/PCA Sizer Sensor Replacement Kit P/N 122786 

The Alaris System is an infusion pump and vital signs monitoring system that delivers fluids, medications, blood and blood products into a patient's body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is used in adult, pediatric and neonatal care. The device is used in hospitals and other healthcare facilities. 

Health professionals, biomedical engineers and rental providers should review and follow the instructions in the recall announcement. 

FDA has the recall

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