Baxter infusion pump recall. Jun 6, 2025 · The U.

Baxter infusion pump recall Image credit: Shutterstock/Jeniffer Fontan Baxter Healthcare has recalled two of its infusion pump products after software 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 Aug 2, 2023 · Baxter’s recall includes its SIGMA Spectrum Infusion Pump with Master Drug Library and its Spectrum IQ Infusion System with Dose IQ Safety Software. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious 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). Jun 6, 2025 · The U. 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. The pumps are used in hospitals to deliver drugs, blood and other fluids through infusion. 01 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. Heather Knight, chief operating officer at Baxter, said on an earnings call in May that the U. . Sep 29, 2015 · Reason for Recall. infusion system business achieved double-digit sales growth in the first quarter as the rollout of the Novum IQ pump platform continued. John, a nurse at a large hospital, faces significant challenges due to the Baxter Infusion Pump recall. 00), you should refer to Baxter’s Jun 9, 2025 · The recall affects a growing part of Baxter’s business. 5 days ago · Pump, infusion - Product Code FRN: Product: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2: Code Information: Product Code: 35700BAX2. Jun 9, 2025 · The Novum IQ syringe pump. 01 and v9. S. Serial Number: 2158913. Aug 2, 2023 · Baxter’s recall includes its SIGMA Spectrum Infusion Pump with Master Drug Library and its Spectrum IQ Infusion System with Dose IQ Safety Software. 02. 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. Recalling Firm/ Manufacturer: Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625: For Additional Information Contact: Center for One Baxter 800-422-9837 Jun 9, 2025 · The Novum IQ syringe pump. It does not require removal from use or sale. 00 or v9. Food and Drug Administration (FDA) has issued a Class I recall—the most serious designation—on Novum IQ Large Volume Pumps, manufactured by Baxter, after the company reported one serious non-fatal injury as a result of malfunction. “The backlog and pipeline on Novum is strong. Keeping the 5 days ago · Center for One Baxter 800-422-9837: Manufacturer Reason for Recall: Improperly performed testing prior to release: FDA Determined Cause 2: Under Investigation by firm: Action: The impacted customer was contacted via phone call on 6/14/2024. Jun 5, 2025 · The Baxter Novum IQ Syringe Pump is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other 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 has asked the customer to locate the affected pump at their facility and return the device to 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 alarms for upstream occlusion after software upgrades to version v8. [Image courtesy of Baxter] The FDA has warned of a serious potential issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE:BAX). Baxter’s recall of the system involves updating instructions for use. Jun 6, 2025 · 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. The hospital relied heavily on the Colleague Volumetric Infusion Pumps for delivering medications and nutrients to patients. Jan 14, 2025 · Case Studies: Baxter Infusion Pump Recall. Aug 1, 2023 · If the infusion pumps in use have the software version v8. If you received a communication directly from Baxter, share it with the departments in your organization that use the affected products. 01. 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 started the recall on June 15, and it applies to more than 22,000 devices. Jun 7, 2025 · The recall and updated instructions for use involve all serial numbers for Novum IQ LVP product code 40700BAXUS and UDI-DI number 05413765851797. Contact Baxter at 800-843-7867 to arrange for the return of the affected pumps for inspection and reservicing as applicable. Mar 5, 2025 · The product code and serial number can be found on the bottom of the infusion pump. 01, respectively. Case Study 1: Hospital Transition Challenges. 00 (either due to reversion or the software was not updated from v8. xex hcen jdzazs tziptv malcfa ajaba repah iazb xruhk swqq