Baxter Healthcare Corporation recalls
279 recalls in our records from 2012 to 2026: 211 FDA medical devices, 68 FDA drugs.
Recalls with full detail pages
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Baxter Healthcare Corporation drug recall: Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
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Baxter Healthcare Corporation drug recall: 0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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Baxter Healthcare Corporation drug recall: Cefazolin in Dextrose
Presence of Particulate Matter
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Baxter Healthcare Corporation medical device recall: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
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Baxter Healthcare Corporation medical device recall: Hillrom VOLARA System P.CIRCUIT KIT
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level…
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Baxter Healthcare Corporation medical device recall: Blue Ventilator Adapter Module
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…
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Baxter Healthcare Corporation medical device recall: Novum IQ LVP
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…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Large Volume Pump
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…
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Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump V6
Certain Spectrum infusion pumps may have an incorrect version of software.
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Baxter Healthcare Corporation medical device recall: Hillrom Q-Link 13 component
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…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ LVP INFUSION SYSTEM
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…
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Baxter Healthcare Corporation medical device recall: Welch Allyn Life2000 Ventilation system
A cybersecurity vulnerability was discovered through internal testing.
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Baxter Healthcare Corporation medical device recall: Baxter Sigma Spectrum Infusion System
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
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Baxter Healthcare Corporation medical device recall: Welch Allyn
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.
Earlier and other recalls
These link to the official agency notice.
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Baxter Healthcare Corporation medical device recall: Likorall Overhead Lifts Product Code: 3121001 Product Description:… Official notice ↗
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap…
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Baxter Healthcare Corporation medical device recall: Brand Name: VOLARA System Product Name: VOLARA Official notice ↗
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing…
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Baxter Healthcare Corporation medical device recall: Pro+ Mrs Surface For Versacare Official notice ↗
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Syringe Pump Official notice ↗
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI)…
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Baxter Healthcare Corporation drug recall: Vancomycin Injection Official notice ↗
CGMP Deviations
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Baxter Healthcare Corporation medical device recall: Adapter for Head Positioning Official notice ↗
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper…
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Baxter Healthcare Corporation medical device recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet… Official notice ↗
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,…
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Baxter Healthcare Corporation medical device recall: Brand Name: Welch Allyn Official notice ↗
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
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Baxter Healthcare Corporation medical device recall: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog… Official notice ↗
Pumps were released without full testing being performed, including occlusion alarm testing.
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Baxter Healthcare Corporation drug recall: Sterile Water for Irrigation Official notice ↗
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
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Baxter Healthcare Corporation medical device recall: SIGMA Spectrum Infusion Pump Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Welch Allyn INF BAG Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Oral Probe Official notice ↗
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the…
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Baxter Healthcare Corporation medical device recall: CONTINU-FLO Solution Set Official notice ↗
IV sets may leak.
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Baxter Healthcare Corporation medical device recall: Baster Continu-Flo Solution Set Official notice ↗
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…
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Baxter Healthcare Corporation drug recall: Acetaminophen Injection 1000 mg/100 mL Official notice ↗
Discoloration
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Baxter Healthcare Corporation medical device recall: Spectrum IQ Infusion Pump Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN… Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Syringe Pump Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Affinity 4 Birthing Bed Official notice ↗
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.
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Baxter Healthcare Corporation medical device recall: Welch Allyn Connex Vital Signs Monitor Official notice ↗
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party,…
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Baxter Healthcare Corporation medical device recall: Welch Allyn Connex Integrated Wall System Official notice ↗
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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Baxter Healthcare Corporation medical device recall: Baxter NovumIQ Syringe INFUSION SYSTEM Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Progressa Bed Surfaces Official notice ↗
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.
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Baxter Healthcare Corporation medical device recall: Baxter Operating table column TS7500 MOBIUS Official notice ↗
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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Baxter Healthcare Corporation medical device recall: Baxter Solution Set with Duo-Vent Spike Official notice ↗
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
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Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Official notice ↗
Devices were identified as released after repair without full testing being performed, which includes flow testing.
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Baxter Healthcare Corporation medical device recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Official notice ↗
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.
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Baxter Healthcare Corporation medical device recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter AK 98 Dialysis Machine Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software Official notice ↗
The door on the Spectrum IQ Infusion pump may not be able to fully close.
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Baxter Healthcare Corporation drug recall: Regadenoson Injection Official notice ↗
Labeling: Missing Label
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Baxter Healthcare Corporation medical device recall: Hillrom Welch Allyn HScribe Holter System Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter Operating table TruSystem 7000 U Official notice ↗
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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Baxter Healthcare Corporation medical device recall: Welch Allyn Life2000 Ventilation System Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter EXACTAMIX Inlet Official notice ↗
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes…
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Baxter Healthcare Corporation drug recall: Heparin Official notice ↗
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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Baxter Healthcare Corporation medical device recall: Baxter Spectrum Wireless Battery Modules A/B/G/N Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump Official notice ↗
Improperly performed testing prior to release
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Baxter Healthcare Corporation medical device recall: Baxter PST 500 U Official notice ↗
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins…
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Baxter Healthcare Corporation medical device recall: Volara System. Single Patient Use Official notice ↗
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and…
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Baxter Healthcare Corporation drug recall: Dianeal Low Calcium Official notice ↗
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
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Baxter Healthcare Corporation medical device recall: Braun Thermoscan¿ PRO 6000 Ear Thermometer Official notice ↗
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
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Baxter Healthcare Corporation medical device recall: Welch Allyn CP150 Electrocardiograph with Spirometry Option Official notice ↗
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that…
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Baxter Healthcare Corporation medical device recall: VidiaPort carrying arm Official notice ↗
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system…
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Baxter Healthcare Corporation medical device recall: Life2000 Ventilator Official notice ↗
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of…
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Baxter Healthcare Corporation medical device recall: Centrella Max - The Centrella Smart+ Bed is intended for use in… Official notice ↗
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of…
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Baxter Healthcare Corporation medical device recall: Spectrum IQ Infusion pump Official notice ↗
There is a potential for cracks on the mount of the front panel of the device.
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Baxter Healthcare Corporation medical device recall: Baxter Spectrum IQ Infusion Pump Official notice ↗
One device was improperly performed testing prior to release from a Service Center.
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Baxter Healthcare Corporation medical device recall: Baxter Seprafilm Adhesion Barrier 1 Half Sheet Official notice ↗
Product was distributed in the United States without proper regulatory approval.
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Baxter Healthcare Corporation medical device recall: Surgical Tools and Cardiovascular Specialty marketing brochures Official notice ↗
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and…
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Baxter Healthcare Corporation medical device recall: Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device Official notice ↗
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international…
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Baxter Healthcare Corporation medical device recall: Hill-Rom PRO+ 36" MRS Surface Official notice ↗
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number:…
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Baxter Healthcare Corporation medical device recall: Baxter Peri-Guard Repair Patch Official notice ↗
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher…
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Baxter Healthcare Corporation medical device recall: HDS Traction Boot II Official notice ↗
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly.…
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Baxter Healthcare Corporation medical device recall: STERIS Boot Assembly Official notice ↗
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to…
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Baxter Healthcare Corporation medical device recall: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter Official notice ↗
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the…
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Baxter Healthcare Corporation drug recall: Norepinephrine Bitartrate in 5% Dextrose Injection Official notice ↗
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label…
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Baxter Healthcare Corporation medical device recall: Baxter Exactamix Pro 1200 Official notice ↗
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can…
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Baxter Healthcare Corporation medical device recall: Baxter Flo-Rester Official notice ↗
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some…
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Baxter Healthcare Corporation medical device recall: Q-Stress Cardiac Stress Testing System Official notice ↗
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
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Baxter Healthcare Corporation medical device recall: Baxter Amia Automated Peritoneal Dialysis Official notice ↗
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
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Baxter Healthcare Corporation drug recall: Ondansetron Injection Official notice ↗
Failed pH Specifications
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Baxter Healthcare Corporation medical device recall: Novum IQ Syringe infusion system Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Hillrom Progressa+ Bed Official notice ↗
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…
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Baxter Healthcare Corporation drug recall: Doxil Official notice ↗
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
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Baxter Healthcare Corporation medical device recall: Baxter Epiphany Cardio Server E3 ECG Management System Servers with… Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Welch Allyn Connex Spot Monitor Official notice ↗
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
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Baxter Healthcare Corporation drug recall: DIANEAL Low Calcium Official notice ↗
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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Baxter Healthcare Corporation drug recall: Bendamustine HCl Injection Official notice ↗
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
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Baxter Healthcare Corporation medical device recall: GEM FLOW COUPLER Monitor Official notice ↗
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,…
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Baxter Healthcare Corporation medical device recall: SIGMA Spectrum Infusion Pump Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Allen Advance Chest Support with Pad Official notice ↗
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
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Baxter Healthcare Corporation medical device recall: Voalte Patient Safety Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Hill-Rom pro+ mattress Official notice ↗
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
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Baxter Healthcare Corporation medical device recall: Gem Neurotube Official notice ↗
The product is brittle and potentially crumbling upon handling or when being removed from its package.
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Baxter Healthcare Corporation drug recall: Dianeal Low Calcium Official notice ↗
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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Baxter Healthcare Corporation medical device recall: ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack Official notice ↗
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
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Baxter Healthcare Corporation medical device recall: Automated Peritoneal Dialysis System. Used for automatic control of… Official notice ↗
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
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Baxter Healthcare Corporation medical device recall: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Life2000 Ventilator System Official notice ↗
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
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Baxter Healthcare Corporation medical device recall: Baxter Electrocardiograph Official notice ↗
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
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Baxter Healthcare Corporation medical device recall: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute… Official notice ↗
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
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Baxter Healthcare Corporation medical device recall: Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic… Official notice ↗
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
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Baxter Healthcare Corporation medical device recall: Hill-Rom Progressa Bed System Official notice ↗
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…
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Baxter Healthcare Corporation medical device recall: Hillrom Centrella Hospital Bed with WatchCare Incontinence Management… Official notice ↗
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner,…
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Baxter Healthcare Corporation medical device recall: Allen Advance Table Official notice ↗
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced…
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Baxter Healthcare Corporation medical device recall: Prismaflex M Set: M60 Official notice ↗
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory…
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Baxter Healthcare Corporation medical device recall: Starling Monitor Official notice ↗
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
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Baxter Healthcare Corporation medical device recall: Baxter CLEARLINK System Official notice ↗
Firm noted an increase in customer reports of leaks.
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Baxter Healthcare Corporation medical device recall: Baxter DISCPAC Syringe Tip Caps Official notice ↗
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
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Baxter Healthcare Corporation medical device recall: The Exacta-Mix 2400 compounding system Official notice ↗
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
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Baxter Healthcare Corporation drug recall: Acetaminophen Injection Official notice ↗
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be…
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Baxter Healthcare Corporation medical device recall: Abacus Tpn Official notice ↗
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
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Baxter Healthcare Corporation medical device recall: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress Official notice ↗
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the…
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Baxter Healthcare Corporation medical device recall: NaviCare Nurse Call/Voalte Nurse Call Official notice ↗
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call,…
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Baxter Healthcare Corporation medical device recall: #1 Mac F/O Laryngoscope Official notice ↗
Packaging error.
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Baxter Healthcare Corporation medical device recall: In-Line ventilator adaptor Official notice ↗
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
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Baxter Healthcare Corporation medical device recall: 15 Liters Drain Bag Official notice ↗
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.