The Recall Desk

FDA (Devices) recall action 85919

CareFusion 303, Inc. recalled 5 products on 2020-08-26

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2020-08-26
Critical
0
Units
1,711,435

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2020-08-26

    CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    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.
    Category
    Distribution
    55 states
  • ModerateFDA (Devices)··2020-08-26

    CareFusion Alaris Pump Module 8100 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    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.
    Category
    Distribution
    55 states
  • ModerateFDA (Devices)··2020-08-26

    CareFusion Alaris Syringe Module LED Display Dimness Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    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.
    Category
    Distribution
    55 states
  • ModerateFDA (Devices)··2020-08-26

    CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    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.
    Category
    Distribution
    55 states
  • ModerateFDA (Devices)··2020-08-26

    CareFusion Alaris PCA Module 8120 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    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.
    Category
    Distribution
    55 states