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Baxter Healthcare Corp

Last updated September 17, 2026

What Baxter Healthcare Corp makes

Baxter Healthcare Corp manufactures intravenous solution compounders like the EXACTAMIX and EXACTAMED, which prepare sterile medications for patient administration. Their portfolio includes intravenous administration sets—such as basic noninvasive sets, tubing extensions, and general-purpose fluid transfer sets—and specialized accessories like the CLEARLINK series (including CLEARLINK/DUO-VENT and CLEARLINK/BURETROL). The company also produces haemostatic agents, including the collagen-based PREVELEAK Surgical Sealant, as well as ENFit-compatible oral/enteral syringes for single-use applications.

These devices are regulated under FDA pathways, with Class I and Class II products subject to 510(k) clearance and Class III devices requiring Premarket Approval (PMA) or De Novo authorisation. The portfolio appears in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. Baxter Healthcare Corp is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 911 NORTH DAVIS, CLEVELAND, MS, 38732
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1019003
DUNS Number: —

Catalogue (771)

Page 15 of 16

Device	Model / Reference	Registries	Class	Status
Varidyne At Postoperative Orthopedic Autotransfu.	K900483	FDA 510(k)	Class II	Active
Vamp Venous/Arterial Blood Management Protection	K885281	FDA 510(k)	Class II	Active
Sepacell(r) Pl-5a/10a Leukocyte Removal Filters	K904221	FDA 510(k)	Class II	Active
Baxter Two Gallon Sharps Disposal Containers	K943605	FDA 510(k)	Class II	Active
Interlink Adapter For Conventional Y-Site	K962893	FDA 510(k)	Class II	Active
Europhilic Slippery Coated Foley Catheter	K944007	FDA 510(k)	Class II	Active
Gram Negative And Positive Mic/Combo Panels	K893977	FDA 510(k)	Class II	Active
Dade Factor Ix Chromogenic Assay	K884551	FDA 510(k)	Class II	Active
Stratus Estradiol Fluoremetric Enzyme	K910249	FDA 510(k)	Class I	Active
The Pudenz In Line Valve	K894072	FDA 510(k)	Class II	Active
Baxject Ii Hi-Flow Needleless Transfer Device	K092318	FDA 510(k)	Class II	Active
Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 With N100 Arm, 4b Software	K013562	FDA 510(k)	Class II	Active
Model Baxter Ultrafiltrate Meter And Drain Bag	K911106	FDA 510(k)	Class II	Active
K-Module Ii Heat Therapy System	K910061	FDA 510(k)	Class II	Active
Accusol Dialysis Solution	K041428	FDA 510(k)	Class II	Active
Sub-Q-Set(r) Subcutaneous Infusion Set	K925362	FDA 510(k)	Class II	Active
Baxter Biostat 1000 Urea Monitor	K925581	FDA 510(k)	Class II	Active
Blood Administration Set	K210335	FDA 510(k)	Class II	Active
Depth Measuring Needles/Vascu Implant Access Set	K861390	FDA 510(k)	Class II	Active
Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys	K893578	FDA 510(k)	Class II	Active
Safesite Injection Site And Blunt Cannula	K883638	FDA 510(k)	Class II	Active
Meridian Hemodialysis Machine, Model 5m5576	K992894	FDA 510(k)	Class II	Active
MiniCap Extended Life PD Transfer Sets	K192705	FDA 510(k)	Class II	Active
Swan-Ganz Therm Cath Sm Heart Amc Throm 93a102h5f	K894168	FDA 510(k)	Class II	Active
Laser Resistant Drape	K873141	FDA 510(k)	Class II	Active
Paclitaxel Sets	K160007	FDA 510(k)	Class II	Active
Ambulatory Infusion Pump System And Solution Sets	K932408	FDA 510(k)	Class I	Active
Interlink System - T-Connector Extension Set	K921899	FDA 510(k)	Class II	Active
Triflex Sterile Synthetic Examination Gloves	K952786	FDA 510(k)	Class I	Active
Sepacell(r) R-200/500 Leukocyte Removal Recip Sets	K904223	FDA 510(k)	Class II	Active
Baxter Marathon(tm) Intravascular Relay Guid Cath	K911367	FDA 510(k)	Class II	Active
Intravascular Extension Sets and Accessories	K192366	FDA 510(k)	Class II	Active
Altapore MIS	K201464	FDA 510(k)	Class II	Active
Dade(r) Ck/Ld Comprehensive Electro. Control	K880175	FDA 510(k)	Class I	Active
Dual Luer Lock Cap, Model 2c6250	K101385	FDA 510(k)	Class II	Active
Fenwal 40 Micron Transfusion Filter	K972159	FDA 510(k)	Class II	Active
One-Day/Five-Day/Seven-Day Syringe Mate	K971168	FDA 510(k)	Class II	Active
Cahp High Performance Cellulose Diacetate Hollow Fiber Dialyzer	K950454	FDA 510(k)	Class II	Active
Clear Hub Spinal Needle, 18, 20, 22, 25 Ga.	K951949	FDA 510(k)	Class II	Active
Baxter Ct Dialyzer	K926568	FDA 510(k)	Class II	Active
Tissomat And Spray Set	K981089	FDA 510(k)	Class II	Active
Cahp High Performance Cellulose Diacetate Hollow Fiber Dialyzer	K950522	FDA 510(k)	Class II	Active
Triflex Orthopedic Sterile Surgeon's Glove	K902380	FDA 510(k)	Class I	Active
Revaclear 500, Revaclear 400, Revaclear 300	K213639	FDA 510(k)	Class II	Active
Control-A-Flo(tm) Regulator	K940867	FDA 510(k)	Class II	Active
C1-Inhibitor Microtiter Assay Device	K003747	FDA 510(k)	Class II	Active
Clinak(tm) Ise Subsystem	K910554	FDA 510(k)	Class II	Active
Half Hour Infusor	K880625	FDA 510(k)	Class II	Active
Vamp Venous/Arterial Blood Management Protection	K896819	FDA 510(k)	Class II	Active
8000 Series Volumetric Pump Solution Set	K914074	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Baxter Healthcare Corp has 436 recall records spanning from July 31, 2009, to April 22, 2026, with statuses including completed, open, classified, and terminated. Recalled items involve issues such as potential leaks in IV sets, misaligned locking pins in traction devices, incomplete testing of pumps, electrical continuity failures in Doppler monitoring devices, discrepancies in drug dose programming, presence of particulate matter or rust in dialyzer components, outdated warnings in user guides, software anomalies in pumps, improper handling of disposable set packaging, leaking pouches, and non-adjustable sections in emergency mode on certain devices.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 22, 2026	Z-2262-2026	—	open, classified	Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Feb 18, 2026	Z-1637-2026	—	open, classified	Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Feb 18, 2026	Z-1573-2026	—	open, classified	Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Jan 13, 2026	Z-1368-2026	—	open, classified	Pumps were released without full testing being performed, including occlusion alarm testing.
Nov 28, 2025	Z-1121-2026	—	open, classified	Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Oct 28, 2025	Z-0847-2026	—	open, classified	Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Sep 17, 2025	Z-0233-2026	—	open, classified	Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Aug 29, 2025	Z-0194-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0196-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0198-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0191-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0199-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0200-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0189-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0192-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0193-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0204-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0202-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0203-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0201-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0197-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0195-2026	—	open, classified	IV sets may leak.
Aug 29, 2025	Z-0190-2026	—	open, classified	IV sets may leak.
Aug 8, 2025	Z-2594-2025	—	open, classified	Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Aug 4, 2025	Z-2334-2025	—	open, classified	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Aug 4, 2025	Z-2333-2025	—	open, classified	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Aug 4, 2025	Z-2332-2025	—	open, classified	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Jul 14, 2025	Z-2415-2025	—	open, classified	Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Jul 14, 2025	Z-2173-2025	—	open, classified	Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
Jun 20, 2025	Z-2095-2025	—	open, classified	Certain Spectrum infusion pumps may have an incorrect version of software.
Jun 20, 2025	Z-2096-2025	—	open, classified	Certain Spectrum infusion pumps may have an incorrect version of software.
May 30, 2025	Z-2032-2025	—	open, classified	The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
May 30, 2025	Z-2031-2025	—	open, classified	The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
May 12, 2025	Z-1964-2025	—	open, classified	Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
May 9, 2025	Z-1962-2025	—	open, classified	The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
May 6, 2025	Z-1816-2025	—	open, classified	There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Apr 24, 2025	Z-1767-2025	—	open, classified	There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Apr 7, 2025	Z-1726-2025	—	open, classified	A cybersecurity vulnerability was discovered through internal testing.
Apr 7, 2025	Z-1725-2025	—	open, classified	A cybersecurity vulnerability was discovered through internal testing.
Mar 24, 2025	Z-1559-2025	—	open, classified	There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Mar 24, 2025	Z-1558-2025	—	open, classified	There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Mar 24, 2025	Z-1560-2025	—	open, classified	There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Mar 21, 2025	Z-1564-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1566-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1568-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1565-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1562-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1567-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 21, 2025	Z-1563-2025	—	open, classified	Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Mar 3, 2025	Z-1423-2025	—	open, classified	Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
Feb 25, 2025	Z-1417-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1412-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1409-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1421-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1418-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1414-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1416-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1411-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1413-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1419-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1420-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1415-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1422-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1410-2025	—	open, classified	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Feb 25, 2025	Z-1468-2025	—	open, classified	The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
Feb 5, 2025	Z-1254-2025	—	open, classified	There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Feb 5, 2025	Z-1253-2025	—	open, classified	There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Dec 20, 2024	Z-1010-2025	—	open, classified	Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Dec 20, 2024	Z-1011-2025	—	open, classified	Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Dec 20, 2024	Z-0887-2025	—	open, classified	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.
Dec 20, 2024	Z-0884-2025	—	open, classified	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.
Dec 20, 2024	Z-0885-2025	—	open, classified	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.
Dec 20, 2024	Z-1009-2025	—	open, classified	Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Dec 20, 2024	Z-0886-2025	—	open, classified	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.
Nov 19, 2024	Z-0776-2025	—	open, classified	Devices were identified as released after repair without full testing being performed, which includes flow testing.
Nov 19, 2024	Z-0775-2025	—	open, classified	Devices were identified as released after repair without full testing being performed, which includes flow testing.
Oct 23, 2024	Z-0569-2025	—	open, classified	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.
Oct 23, 2024	Z-0563-2025	—	open, classified	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.
Oct 23, 2024	Z-0560-2025	—	open, classified	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.
Oct 23, 2024	Z-0566-2025	—	open, classified	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.
Oct 23, 2024	Z-0564-2025	—	open, classified	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.
Oct 23, 2024	Z-0559-2025	—	open, classified	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.
Oct 23, 2024	Z-0568-2025	—	open, classified	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.
Oct 23, 2024	Z-0567-2025	—	open, classified	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.
Oct 23, 2024	Z-0562-2025	—	open, classified	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.
Oct 23, 2024	Z-0565-2025	—	open, classified	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.
Oct 23, 2024	Z-0561-2025	—	open, classified	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.
Oct 21, 2024	Z-0378-2025	—	open, classified	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.
Oct 21, 2024	Z-0374-2025	—	open, classified	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.
Oct 21, 2024	Z-0377-2025	—	open, classified	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.
Oct 21, 2024	Z-0376-2025	—	open, classified	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.
Oct 21, 2024	Z-0379-2025	—	open, classified	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.
Oct 21, 2024	Z-0380-2025	—	open, classified	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.
Oct 21, 2024	Z-0381-2025	—	open, classified	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.
Oct 21, 2024	Z-0382-2025	—	open, classified	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.
Oct 21, 2024	Z-0375-2025	—	open, classified	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.
Oct 21, 2024	Z-0373-2025	—	open, classified	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.
Oct 16, 2024	Z-0327-2025	—	open, classified	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.
Oct 11, 2024	Z-0322-2025	—	open, classified	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.
Oct 11, 2024	Z-0320-2025	—	open, classified	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.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Baxter Healthcare SA CH