CareFusion 303, Inc.: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

Agency Publication Date: August 19, 2020

Affected Products

Product: Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

All serial numbers

Product: Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

All serial numbers

Product: Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

All serial numbers

Product: Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

All serial numbers

Product: Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85919

Status: Active

Manufacturer: CareFusion 303, Inc.

Manufactured In: United States

Units Affected: 5 products (1442097; 130612; 89497; 40671; 8558)

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Sources: FDA iRES · FDA Press Release · Raw API Response

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Affected Products

All serial numbers