Baxter Healthcare Recalls

Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Hazard: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Hazard: Failed pH Specifications

Hazard: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.

Hazard: Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.

Hazard: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Hazard: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

Hazard: Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Hazard: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Hazard: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

Hazard: Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Hazard: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Hazard: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Hazard: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

Hazard: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

Hazard: There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

Hazard: The product is brittle and potentially crumbling upon handling or when being removed from its package.

Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Hazard: ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

Hazard: The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Hazard: MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

Hazard: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Hazard: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Hazard: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Hazard: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Hazard: One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

Hazard: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak