Baxter Healthcare Corporation
190 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Baxter Healthcare Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-12FDA-DeviceClass IBaxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- 2025-03-12FDA-DeviceClass IBaxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- 2025-01-29FDA-DeviceClass IIBaxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- 2025-01-29FDA-DeviceClass IIBaxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- 2025-01-29FDA-DeviceClass IIBaxter Solution Set with Duo-Vent Spike, REF 2R8404
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- 2025-01-22FDA-DeviceClass IBreathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceClass IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceClass IWelch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-22FDA-DeviceClass IWelch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-08FDA-DeviceClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Devices were identified as released after repair without full testing being performed, which includes flow testing.
- 2025-01-08FDA-DeviceClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Devices were identified as released after repair without full testing being performed, which includes flow testing.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
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