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.
- 2024-11-27FDA-DeviceClass IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; 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 5C4482; 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.
- 2024-11-20FDA-DeviceClass IIBaxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
The door on the Spectrum IQ Infusion pump may not be able to fully close.
- 2024-11-20FDA-DeviceClass IBaxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
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.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceClass IIHillrom Welch Allyn HScribe Holter System; ambulatory monitoring
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DrugClass IIRegadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01
Labeling: Missing Label
- 2024-11-06FDA-DeviceClass IIa. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P790
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 V, Product code REF 1841050
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating Table TruSystem 7000, Product code REF 1841046
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IIBaxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceClass IWelch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- 2024-09-25FDA-DeviceClass IBaxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
- 2024-09-25FDA-DeviceClass IBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
- 2024-09-25FDA-DeviceClass IBaxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
- 2024-09-25FDA-DeviceClass IBaxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
- 2024-09-11FDA-DrugClass IHeparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2024-08-28FDA-DeviceClass IISpectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
- 2024-08-28FDA-DeviceClass IIBaxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
- 2024-08-14FDA-DeviceClass IIBaxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Improperly performed testing prior to release
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