WebJan 20, 2024 · Petitioners are urging the Commissioner of Food and Drugs to issue a corrective recall requiring certain modifications to the Fresenius 2008K2, 2008T, and … WebFor over 30 years, the Fresenius Renal Technologies team has partnered with our customers to deliver the highest quality product support documentation and marketing updates. Caution: Federal (US) law restricts these devices to sale by or on the order of a physician. Note: Read the Instructions for Use for safe and proper use of these devices ...
What is a Medical Device Recall? FDA
WebIt is meant to be used with at-home dialysis machines manufactured by NxStage. NxStage Dialysis Fluid Recall. In May 2014, NxStage issued a recall for about 140,000-150,000 units of SAK Dialysis Concentrate after discovering high levels of aluminum. Although NxStage could not say how many users received the products, they were sold from April ... WebHome Hemodialysis allows me to turn precious moments into memories. With the opportunity to dialyze during the day, overnight, or even while traveling, patients may find what was once impossible possible. NxStage … toppers pizza oxnard order online
Baxter Support - US Renal Care
The FDA recognizes that hemodialysis machines are critical to patient care. Health care providers should work with their patients to ensure that patients get the dialysis treatment they need. At this time, the FDA has the following recommendations for health care providers: 1. Continue to provide dialysis treatments to … See more Hemodialysisis one type of therapy used to treat patients who develop severe acute kidney injury or end-stage renal (kidney) disease. A … See more The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with hemodialysis machines manufactured by Fresenius Medical Care. Prompt reporting can help … See more The FDA has requested the manufacturer to conduct additional testing to further evaluate the issue and to implement mitigation strategies. The FDA will inform the public when … See more If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). See more WebOutset Medical, Inc. 3052 Orchard Dr. San Jose CA 95134-2011. For Additional Information Contact. Jennifer Mascioli-Tudor. 669-231-8200. Manufacturer Reason. for Recall. Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. WebJan 20, 2014 · The recall impacts the Fresenius 2008 Series Hemodialysis Machines with model numbers 2008H, 2008K, 2008K2, 2008k@Home, and 2008T. According to the FDA, 111,504 units were sold in the U.S., and ... toppers pizza chelmsford phone number