The U.S. Food & Drug Administration’s recall covers as many as 200,000 of Baxter International Inc.’s Colleague infusion pumps.
The Food & Drug Administration issued its final order for the U.S. recall of Baxter International Inc.’s (NYSE:BAX) Colleague infusion pumps.
The federal watchdog is requiring the Deerfield, Ill.-based company to provide transition guide for hospitals and clinics using Colleague infusion pumps.
The Power of Real World Data to Study Women’s Health at Scale
Veradigm examines key clinical trends, comorbidity profiles, and treatment trends across adolescence, reproductive years, and peri-/post-menopause. Download it today!
The guide will include a list of FDA-cleared or approved pump alternatives and information on refund, replacement and lease termination programs, the regulatory agency said.
Baxter will carry out the the recall over the next two years. The company said it will offer replacement infusion pumps or refunds to owners of Colleague pumps, and it is offering Sigma Spectrum pumps in exchange for the recalled pumps. Otherwise, owners can collect on the Colleague’s depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, according to the company. Pump lessees can terminate their leases without penalty.
The recall is the latest in a series of unfortunate news for the company. In June, FDA warned Baxter over the watchdog agency’s concerns about the company’s HomeChoice peritoneal dialysis systems, after reports surfaced of at least four patients developing peritonitis. It wasn’t the first time the HomeChoice system has created serious problems for patients. In March, the FDA issued a Class 1 recall for several models of the device, saying a problem with the dialysis machine is causing “increased intraperitoneal volume” or an overfill of the abdominal cavity with liquid, leading to injuries and at least one reported death.
Top 7 Modern AI-Powered EAP Providers for Global Workforces in 2026
Discover the top AI-powered EAP providers for 2026. Compare platforms like Kyan Health and Spring Health on triage speed, global reach, and clinical quality to transform workforce wellbeing.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.