Overview of recall records associated with Baxter Healthcare Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 260, Class I: 60, Class III: 8.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
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…
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…
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
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…
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…
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…
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
The product is brittle and potentially crumbling upon handling or when being removed from its package.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
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…
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs.,…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
This page summarizes recall records in which the official source identifies Baxter Healthcare Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
