{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 8 } }, "results": [ { "cfres_id": "217802", "product_res_number": "Z-1224-2026", "event_date_initiated": "2026-01-06", "event_date_posted": "2026-02-02", "recall_status": "Open, Classified", "res_event_number": "98180", "product_code": "KDI", "k_numbers": [ "K212216" ], "product_description": "PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System", "code_info": "UDI/DI 00085412954073, All lots including and manufactured after 24G0072", "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 customer service\n800-284-4060", "reason_for_recall": "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.", "root_cause_description": "Component design/selection", "action": "Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: \n1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. \n2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following: \n . Ensure there are no kinks in the tubing and that the deaeration chamber remains visible.\n . If the Prismaflex Control Unit issues an Air in Blood alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. \n1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. \n2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. \n3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. \nFacilities who further distributed the products were directed to notify those departments or facilities.\nDealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. \nFor general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.", "product_quantity": "87,436 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K923312", "K841152", "K952983", "K811830", "K243920", "K051187", "K994198", "K840680", "K962427", "K072232", "K162488", "K050525", "K030099", "K832547", "K992573", "K071518", "K971180", "K910236", "K873887", "K023664", "K973322", "K122051", "K041726", "K083158", "K001283", "K121409", "K992566", "K010805", "K980859", "K131908", "K131935", "K823881", "K923727", "K023509", "K955592", "K860938", "K012510", "K032431", "K942681", "K222952", "K152367", "K001156", "K080964", "K231125", "K250508", "K781464", "K123288", "K070512", "K140866", "K232803", "K832645", "K963440", "K253412", "K830595", "K834589", "K192928", "K131381", "K003498", "K961465", "K854586", "K131050", "K982926", "K193482", "K024124", "K955487", "K193005", "K003425", "K173972", "K211370", "K852251", "K071263", "K002277", "K911094", 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