Baxter infusion pump recall. This story has been updated.

Baxter infusion pump recall announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. This story has been updated. 2 billion, was given many chances to fix design flaw problems with its Colleague Volumetric Infusion Pumps, but never did. The recall follows reports of unwanted particulate matter found within the inlets, including the sterile tubing. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U. Mar 5, 2025 · These Baxter Spectrum infusion pumps are intended to be used for the controlled administration of fluids—including medicine, blood, and blood products—to patients. Current Problems with the Infusion Pump. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health Baxter infusion pump recall reported by FDA. In the past five years, the FDA has received more than 56,000 reports of adverse events Jun 15, 2023 · Recall Number: Z-2103-2023: Recall Event ID: 92562: 510(K)Number: K230022 : Product Classification: Pump, infusion - Product Code FRN: Product: SIGMA Spectrum Infusion Pump, Product Code 35700BAX2: Code Information: GTIN 00085412498683, Software version v8. Recalling Firm/ Manufacturer: Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625: For Additional Information Contact: Center for One Baxter 800-422-9837 Aug 1, 2023 · The two products recalled are the SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9). The agency on Friday labeled it the most serious type of recall given that Baxter has received 51 reports of serious injuries and three reports of patient deaths over a five-year period. Oct 29, 2020 · Baxter International Inc. Contact Baxter Recall Status 1: Open 3, Classified: Recall Number: Z-0775-2025: Recall Event ID: 95848: 510(K)Number: K133801 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX: Code Information: GTIN 00085412091570; Serial Number: 779515 Jan 14, 2025 · Baxter Healthcare Colleague Infusion Pump Recall Baxter Healthcare, the U. Extract: Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. This communication came as part of the FDA’s pilot to enhance its medical device recall program. and 6 p. Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased reports of false alarms for upstream occlusion after pump software upgrades to version v8. In the meantime, healthcare providers may continue to safely use the Novum IQ LVPs while following the Instructions for Use. Aug 2, 2023 · Baxter is recalling two of its infusion pumps due to a risk that the devices could give a false alarm for an upstream occlusion, or tubing blockage, interrupting or delaying treatment. subsidiary of global medical device maker Baxter International’ which reported 2008 earnings of $2. The following must be confirmed by the pump operator prior to starting an infusion or initiating a drug titration: i. with adverse reactions, quality problems, or questions about this recall should contact Baxter Healthcare Center for Service at 888-229-0001 or corporate_product_complaints Jul 28, 2023 · Baxter International Inc. DEERFIELD, Ill. The device is suitable for patient care in hospitals and outpatient facilities for adults, pediatrics and neonates. Jun 30, 2020 · Recall Number: Z-0120-2021: Recall Event ID: 86062: 510(K)Number: K042121 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Code Information: Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570: Recalling Firm/ Manufacturer: Baxter Aug 1, 2023 · Editor's Note. Nov 29, 2023 · This infusion pump is distributed in the United States. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8. Serial Number: 2158913. Baxter is advising all customers who plan prolonged storage of Spectrum pumps and batteries to ensure the following: Batteries are charged to 2 or 3 bars prior to storage (do not fully charge); Batteries are stored between -10 and +35 degrees C (14 and 95 degrees F); Batteries are removed from the pump and stored independent of the pumps; and Baxter will contact customers regarding the replacement of keypads on affected pumps. Food and Drug Administration. S. Code Information: All serial numbers, GTIN 00085412610900. , as a Class I event. The FDA cleared the Novum IQ infusion pump with Dose IQ safety software in August 2022. 15 recall, not a notification for a separate recall. Code Information: All serial numbers, GTIN 00085412498683 Aug 2, 2023 · On August 1, 2023, the U. The issue, which is thought to have arisen during the servicing process, may lead to ‘insufficient or excessive’ therapy, therapy interruption, or delays in therapy, the company said, all of which can result in serious adverse Sep 29, 2015 · Reason for Recall. Recalling Firm/ Manufacturer: Baxter Healthcare Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues The FDA has identified this as a Class I recall, the most serious type of recall. Recently announcing the recall, the company reported that its Sigma Spectrum Infusion Pump with Master Drug Library (version eight) and Spectrum IQ Infusion System with Dose IQ Safety Mar 5, 2025 · FDA Alerts on Baxter Infusion Pump Recall – The FDA has issued an early alert on the recall of Baxter’s Spectrum infusion pumps due to missing motor mounting screws that may compromise therapy delivery. Baxter infusion pumps are calibrated for use solely with Baxter proprietary IV sets. The information on this page is provided for information purposes only. The FDA notes that, despite the recall notice, a set of updated instructions will render the pumps safe to use—meaning, there is no need to find a replacement. 02. Customers who are not experiencing leak complications should continue to use Baxter Healthcare has once again found itself in the depths of a Class I recall for its infusion pump systems. - 2022-02-17 Baxter International Inc. A few weeks ago, the FDA deemed a Novum IQ recall Class I because the pump may incorrectly indicate the Feb 17, 2022 · PDF . Customers with additional questions can contact their Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday between 6 a. Baxter (NYSE:BAX) issued an urgent medical device correction notice regarding its Novum IQ syringe infusion pump. We are writing to inform you that the FDA has issued a Class 1 recall of Baxter Healthcare Corporation’s SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased reports of false 3 days ago · The devices are used for intravenous infusion of parenteral fluids, blood and blood products to a patient in a medical setting, such as a hospital or clinic. Food and Drug Administration (FDA) has issued a Class I recall on behalf of Baxter Healthcare for the company’s disposable inlets, used with ExactaMix automated compounding systems. [Image courtesy of Baxter/FDA] The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. Image credit: Shutterstock/Jeniffer Fontan Baxter Healthcare has recalled two of its infusion pump products after software Feb 22, 2022 · UPDATE: March 14, 2022: FDA has classified Baxter International's infusion pump recall, impacting more than 270,000 devices in the U. 2 days ago · The recall and updated instructions for use involve all serial numbers for Novum IQ LVP product code 40700BAXUS and UDI-DI number 05413765851797. 01 and v9. After an upstream occlusion alarm, failure to May 3, 2010 · Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems. Feb 18, 2022 · Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions and referencing the Operator’s Manual for infusion setup instructions in the Nov 16, 2023 · Fresenius Medical Care Baxter Class I recall infusion pump. Feb 21, 2022 · The action does not constitute a Baxter infusion pump recall, and medical providers can continue to use the Spectrum V8 and Spectrum IQ pumps. with questions should contact your Baxter sales representative or Baxter Global Technical Services at 800-843-7867 Monday through Friday Jun 2, 2025 · Pump, infusion - Product Code FRN: Product: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2: Code Information: Product Code: 35700BAX2. The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious. The Baxter Colleague Recall Status 1: Open 3, Classified: Recall Number: Z-1254-2025: Recall Event ID: 96289: 510(K)Number: K230041 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009: Code Information Aug 24, 2021 · Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s The lawyers at Saiontz & Kirk are no longer investigating Baxter Infusion Pump Lawsuits. In that case, the versions 8. Aug 1, 2023 · Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased reports of Oct 13, 2023 · Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. 01. Keeping the Mar 20, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall The product code and serial number can be found on the bottom of the infusion pump. Nov 30, 2023 · Baxter International Inc. 5 days ago · 3. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Baxter has issued multiple On May 3, 2010, Baxter Healthcare Corporation announced a recall of its Colleague volumetric infusion pumps, widely used in hospitals and other healthcare facilities to deliver medication and other fluids to patients. and Puerto Rico that have been upgraded to Dec 29, 2021 · Recall Status 1: Open 3, Classified: Recall Number: Z-0529-2022: Recall Event ID: 89017: 510(K)Number: K173084 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter Spectrum IQ Infusion Pumps, Product code 3570009. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health Early reported problems included software errors, pump motor failures, premature battery failures, failures of one channel in the triple channel Colleague pumps that would cause all three channels to stop operating, and random failure codes. and Puerto Rico that have been upgraded to software versions v8. Dec 1, 2023 · Baxter issued a notification related to a Nov. Baxter recalled nearly 23,000 of its devices in August 2023 due to software issues – the FDA also tagged this event as Class I. is being forced to recall 200,000 Colleague Volumetric Infusion pumps due to what federal safety reviewers say are a number of serious safety problems. Recalled Products Mar 13, 2009 · The Baxter infusion pump recall applies to about 275,000 of the Colleague Single and Triple Channel Volumetric pumps that were manufactured and sold from February 1997 through December 2008. Keeping the Aug 11, 2022 · Baxter is voluntarily issuing this Urgent Medical Device Recall with the knowledge of the U. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps Recall Status 1: Open 3, Classified: Recall Number: Z-1423-2025: Recall Event ID: 96388: 510(K)Number: K242390 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS: Code Information Mar 6, 2025 · Baxter said the Spectrum infusion pumps are being recalled due to the potential of missing motor mounting screws. Oct 1, 2024 · What is the Novum IQ Syringe Infusion Pump? The Novum IQ syringe infusion pump is a sophisticated device used to deliver fluids, medication, and nutrients to patients. The issue, which is thought to have arisen during the servicing process, may lead Baxter Healthcare Corporation Baxter NovumIQ Syringe Infusion System Recall Date Product Description Recalling Firm Recall Reason 03/21/2025 Baxter NovumIQ Syringe Infusion System REF: 40800BAXUS Baxter Healthcare Corporation Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due Mar 21, 2025 · The company is far from the only manufacturer experiencing infusion pump woes due to problematic software. m. The recall occurred due to a software Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues The FDA has identified this as a Class I recall, the most serious type of recall. 1 During the past few years, the Colleague series infusion pumps have been involved in a number of Mar 6, 2025 · Baxter said the Spectrum infusion pumps are being recalled due to the potential of missing motor mounting screws. However, in the event of an upstream occlusion alarm Mar 5, 2025 · The Sigma Spectrum and Spectrum IQ infusion systems. 00 and Nov 16, 2023 · Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The Correction is due to the potential for an incomplete Mar 5, 2025 · Customers in the U. 01, Serial Numbers: Recalling Firm/ Manufacturer: Baxter Healthcare Corporation 1 Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion Mar 6, 2025 · Baxter Healthcare has issued a recall for some Spectrum infusion pumps due to a potential defect involving missing motor mounting screws, which could lead to interruptions, delays or incorrect Jul 31, 2023 · Baxter International Inc. . Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Mar 5, 2025 · The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The Correction is due to an increase in reported false upstream occlusion alarms following the software upgrades. Sep 24, 2024 · The U. In its second and third such notices this week, the FDA doled out its most serious label to a pair of recalls of devices used in Dec 29, 2021 · Recall Status 1: Open 3, Classified: Recall Number: Z-0530-2022: Recall Event ID: 89017: 510(K)Number: K133801 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. Jun 4, 2021 · RE: Spectrum IQ Infusion Pump software upgrade, Follow-up Communication to June 4, 2021 Urgent Medical Device Correction August 2, 2021 Dear Directors of Biomedical Engineering, Risk Management, Nursing, and Information Technology: On June 4, 2021, Baxter issued an Urgent Medical Device Correction letter for all Spectrum IQ infusion pumps. Recall Event ID: 94988: 510(K)Number: K230022 : Product Classification: Pump, infusion - Product Code FRN: Product: Baxter 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: Code Mar 5, 2025 · Baxter Healthcare Corporation recalled the Spectrum infusion pumps because of the potential for missing motor mounting screws, which may have occurred during the servicing process. Contact Information Customers in the U. Mar 5, 2025 · Baxter Healthcare Corporation recalled the Spectrum infusion pumps because of the potential for missing motor mounting screws, which may have occurred during the servicing process. Use of these devices may cause serious injuries or death. 4 days ago · Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion or questions about this recall should contact Baxter at 847-948-4770. May 4, 2010 · Baxter Healthcare Corp. Aug 12, 2021 · Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump. Central Time. 01, respectively. It plays a crucial role in scenarios where precise dosages are necessary, particularly in a clinical setting. In the recall, Baxter said that it became aware of the potential for underinfusion with the Novum IQ LVP following use of standby mode or powering the pump off with the set loaded. Baxter does not have replacement solution sets for product code 2R8403 and currently has limited supply of non-DEHP alternative solution sets. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across Aug 1, 2023 · The now-recalled versions of both drug-dosing software programs were themselves originally meant to be a fix for Baxter’s last Class I infusion pump recall. Certain Baxter infusion pumps have been recalled as a result of problems which could cause the interruption of life-sustaining medicine. nlcoq ubnxo npj gtpm igkh xiszdzk pqavm heicyg aazp qpagv