{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "214932", "product_res_number": "Z-2437-2025", "event_date_initiated": "2025-07-28", "event_date_posted": "2025-08-26", "recall_status": "Open, Classified", "res_event_number": "97233", "product_code": "KDI", "k_numbers": [ "K190910" ], "product_description": "PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701", "code_info": "UDI 00085412639499, All Serial Numbers", "firm_fei_number": "3038195011", "recalling_firm": "VANTIVE US HEALTHCARE LLC", "address_1": "510 Lake Cook Rd", "city": "Deerfield", "state": "IL", "postal_code": "60015-4964", "additional_info_contact": "Vantive's customer service\n800-284-4060", "reason_for_recall": "Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles", "root_cause_description": "Under Investigation by firm", "action": "Vantive issued an Urgent Medical Device Correction notice to it consignees on 0728/2025 via USPS first class mail. The notice explained the issues with the devices, hazard involved, and requested the following: \nActions to be Taken by Customers\n1. Operators may continue to safely use the PrisMax Systems and TherMax Blood Warmer Units per the associated Operator s Manuals and on-screen instructions. \nIf further assistance is required, please contact your local Vantive account representative. Please ensure that all operators of these devices are made aware of this Urgent Medical Device Correction notification. Vantive recommends that a copy of this notification is posted within the appropriate location of your facility. \n2. As corrections become available, a local Vantive representative will contact your facility to determine the correction plan and schedule the associated correction(s) for impacted devices. \n3. If you received this communication directly from Vantive, complete the enclosed Vantive Customer Reply Form and return it to Vantive by scanning and e-mailing it to FieldActions@vantive.com. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive an email and/or phone call from\nVantive to confirm your receipt of this notification. \n4. If you purchased this product from a distributor, please note that responding using the Vantive Customer Reply Form is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions.\n5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. \n6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your", "product_quantity": "4772 units", "distribution_pattern": "Worldwide", "openfda": { "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2", "k_number": [ "K864587", "K946279", "K952982", "K030974", "K030975", "K890315", "K252377", "K061519", "K220721", "K840543", "K992564", "K963203", "K193005", "K121409", "K945542", "K830487", "K170469", "K034064", "K133547", "K910236", "K171331", "K210661", "K110823", "K852885", "K123262", "K131516", "K111639", "K060195", "K120017", "K031378", "K010985", "K193482", "K242155", "K844790", "K823338", "K091978", "K070222", "K143313", "K933883", "K131935", "K100334", "K143482", "K900018", "K823881", "K854586", "K231125", "K974584", 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