CareFusion 303, Inc.: Medical Device Recalls in 2020

According to to data from the FDA, there were 25 medical device recalls made by CareFusion 303, Inc. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
• BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
• Alaris System PC Unit Model 8015
• PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
• BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
• Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
• Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
• Alaris Pump Module Model 8100
• Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
• Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
• Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
• Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
• Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
• Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
• Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
• CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
• CareFusion Alaris PCA Module, Model 8120
• CareFusion Alaris Pump Module, Model 8100
• CareFusion Alaris Syringe Module, Model 8110
• 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.
• 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.
• 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.
• 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.
• 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.
• BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.