{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "165648", "product_res_number": "Z-2793-2018", "event_date_initiated": "2018-06-11", "event_date_created": "2018-08-14", "recall_status": "Terminated", "event_date_terminated": "2020-04-28", "res_event_number": "80512", "product_code": "KDI", "k_numbers": [ "K071263" ], "product_description": "NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)\n\nProduct Usage:\nThe NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.", "code_info": "All units are affected. As of 6/11/18, the last serial number manufactured was W35452.", "firm_fei_number": "3003464075", "recalling_firm": "NxStage Medical, Inc.", "address_1": "350 Merrimack St", "city": "Lawrence", "state": "MA", "postal_code": "01843-1748", "additional_info_contact": "Customer Service\n800-697-8243", "reason_for_recall": "There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported.", "root_cause_description": "Use error", "action": "On June 11, 2018, the firm distributed Medical Device Product Safety Notices to affected customers and dialysis centers. Patients were contacted either via email or UPS second day air. Dialysis centers were contacted via email.\n\nThe recall communication alerted customers that the firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse health consequences or medical interventions have been reported. The firm informed customers that they were updating the User Guide to add the following new warning language:\n\n\"Warning: Do not use any fluid bags that are leaking, and use caution not to spill fluids near the\nwarmer. If the warmer is plugged in, leaking or spilled fluids in the warmer power receptacle can cause\nan electrical short even if the warmer is not being used. This can lead to an electrical fire and risk of\nserious injury or death. To minimize this risk, do the following:\n\" When not used during treatment, do not plug the Express Fluid Warmer into the cycler.\n\" Check all fluid bags for leaks prior to and during use.\n\" If fluid spills onto the warmer, unplug the warmer power cord from the rear power receptacle\nand contact Technical Support.\"\n\nCustomers were asked to do the following: \n1. Please follow the instructions on the attached reply form to confirm that you received this notice.\n2. Please observe the above warning and unplug your Express Fluid Warmer when not in use.\n\nIf you have any questions or comments,\nplease feel free to contact Customer Service at 1-800-NXSTAGE.", "product_quantity": "14975", "distribution_pattern": "Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.", "openfda": { "k_number": [ "K823589", "K926568", "K974584", "K120017", "K973516", "K001283", "K872767", "K123262", "K140191", "K123288", "K062079", "K841152", "K854586", "K232776", "K133547", "K071298", "K780527", "K990643", "K903641", "K032356", "K071263", "K952978", "K830487", "K962707", "K850866", "K864169", "K900918", "K192928", "K041005", "K023509", "K955384", "K820243", "K992563", "K994267", "K110823", "K911603", "K030099", "K121341", "K883407", "K832547", "K023664", "K923312", "K122347", "K980386", "K013562", "K062922", "K040489", "K032431", "K232171", "K112314", "K003498", 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