{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2341-2024.jsonld", "@type": "schema:Dataset", "name": "190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A", "description": "FDA recall Z-2341-2024 — Fresenius Medical Care Holdings, Inc. is recalling 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2341-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A", "manufacturer": { "@type": "schema:Organization", "name": "Fresenius Medical Care Holdings, Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2341-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-2341-2024: Fresenius Medical Care Holdings, Inc. is recalling 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A", "text": "The FDA logged enforcement record Z-2341-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A — reason: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-03. Affected lots/codes: Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 4K0S192528, 4K0S192538, 4K0S192235, 4K0S192231, 4K0S192236, 4K0S192237, 2K0S180521, 2K0S180522, 2K0S180527, 3K0S186036, 3K0S182626, 3K0S182627, 3K0S182637, 3K0S182646, 3K0S184910, 3K0S185719, 3K0S185721, 3K0S185739, 3K0S185742, 3K0S186938, 3K0S186951, 3K0S186953, 3K0S186960, 3K0S186995, 3K0S186997, 4K0S190280, 4K0S191586, 4K0S191229, 4K0S191230, 4K0S191232, 4K0S191569, 4K0S191579, 4K0S191580, 4K0S192727, 4K0S192731, 2K0S179494, 2K0S179487, 3K0S182636, 4K0S192226, 4K0S192227, 4K0S192234, 4K0S192239, 4K0S192241, 4K0S192245, 3K0S186032, 3K0S184877, 3K0S184878, 3K0S184895, 3K0S185724, 3K0S185736, 3K0S186042, 3K0S186935, 3K0S186990, 4K0S190518, 4K0S190524, 4K0S191584, 4K0S192242, 4K0S192737, 3K0S182658, 4K0S191129, 4K0S191133, 4K0S192537, 4K0S192230, 2K0S180524, 2K0S180526, 3K0S185720, 2K0S180530, 2K0S180542, 4K0S190538, 4K0S191124, 3K0S184906, 4K0S191233, 3K0S185978, 3K0S186944, 2K0S181716, 3K0S182642, 3K0S185975, 2K0S180516, 3K0S186993, 2K0S179479, 2K0S180529, 2K0S180533, 2K0S179490, 3K0S182656, 3K0S184887, 3K0S182645, 3K0S182655, 2K0S179482, 2K0S179477, 3K0S182635, 3K0S185997, 3K0S186948, 3K0S184893, 4K0S191234, 1K0S172200, 2K0S179485, 1K0S171809, 4K0S191582, 1K0S171481, 3K0S182650, 3K0S186992, 3K0S182654, 3K0S185981, 3K0S186044, 1K0S172057, 4K0S191512, 3K0S185729, 3K0S185979, 3K0S182641, 3K0S182643, 3K0S184890, 4K0S192526, 4K0S192533, 4K0S192729, 4K0S192735, 1K0S171848, 1K0S172052, 3K0S185735, 3K0S184884, 3K0S184892, 1K0S171482, 4K0S191136, 4K0S191122, 4K0S191125, 4K0S191134, 4K0S191123, 4K0S191141, 4K0S192243, 4K0S192244, 4K0S192540, 4K0S190531, 3K0S184891, 3K0S185723, 3K0S185745, 3K0S185988, 3K0S186956, 3K0S187002, 1K0S171808, 4K0S190513, 3K0S185718, 4K0S190511, 4K0S190530, 3K0S182625, 2K0S181709, 2K0S181711, 3K0S186034, 3K0S186998, 3K0S186942, 1K0S172061, 1K0S171825, 1K0S171841, 1K0S171483, 1K0S171815, 2K0S179500, 2K0S181717, 3K0S186950, 3K0S185998, 3K0S184899, 4K0S192730, 4K0S190533, 3K0S185741, 3K0S186962, 4K0S190516, 3K0S185737, 3K0S185728, 4K0S192240, 4K0S192233, 3K0S185310, 2K0S180512, 2K0S180543, 4K0S190846, 3K0S185743, 1K0S172045, 3K0S184879, 3K0S184881, 3K0S184905, 3K0S186933, 2K0S179499, 2K0S179501, 2K0S181719, 3K0S187001, 3K0S186947, 3K0S185994, 3K0S185983, 1K0S172189, 3K0S184907, 3K0S185311, 3K0S184868, 3K0S186989, 3K0S186941, 4K0S192517, 1K0S171818, 4K0S191581, 1K0S171477, 1K0S171498, 2K0S181705, 4K0S192228, 1K0S171839, 1K0S171843, 3K0S186039, 4K0S191139, 4K0S191588, 1K0S171822, 1K0S171829, 2K0S181715, 3K0S182633, 3K0S182638, 3K0S186037, 4K0S190520, 2K0S180525, 2K0S180518, 3K0S185974, 1K0S171479, 3K0S184902, 1K0S171494, 3K0S184865, 3K0S184867, 3K0S184875, 3K0S184889, 3K0S185977, 3K0S185987, 3K0S185996, 3K0S182648, 2K0S181706, 1K0S172042, 3K0S185726, 3K0S186958, 4K0S192536, 3K0S185716, 4K0S192512, 4K0S192728, 1K0S171838, 2K0S181710, 3K0S185992, 4K0S190527, 4K0S190541, 2K0S180546, 3K0S186954, 3K0S182647, 3K0S184874, 3K0S185283, 4K0S190532, 4K0S190534, 3K0S182659, 1K0S171811, 1K0S171832, 1K0S171844, 3K0S186996, 3K0S186999, 3K0S185725, 3K0S185727, 3K0S185982, 4K0S190844, 4K0S190526, 4K0S191570, 1K0S171492, 3K0S186952, 1K0S171491, 3K0S182634, 2K0S181708, 3K0S186991, 3K0S186040, 3K0S185717, 1K0S172192, 2K0S179495, 3K0S182644, 4K0S190539, 4K0S190845, 4K0S190847, 4K0S192527, 1K0S172049, 3K0S182632, 3K0S182651, 3K0S186041, 2K0S179496, 3K0S186939, 4K0S192734, 3K0S185995, 4K0S191140, 3K0S184911, 1K0S172182, 4K0S191131, 4K0S191135, 2K0S181713, 4K0S191130, 3K0S184908, 4K0S192229, 4K0S190522, 1K0S172185, 4K0S192530, 2K0S180517, 2K0S180531, 4K0S190852, 4K0S190853, 2K0S179488, 4K0S191231, 3K0S184894, 2K0S179484, 3K0S182652, 3K0S182657, 4K0S192516, 4K0S190543, 1K0S172059, 1K0S172190, 3K0S184872, 3K0S182629, 3K0S185985, 3K0S186946, 4K0S190512, 1K0S172186, 1K0S172188, 1K0S171810, 1K0S171831, 1K0S171828, 1K0S171842, 3K0S185284, 3K0S185309, 3K0S185722, 3K0S184903, 4K0S190850, 3K0S185281, 3K0S186043, 3K0S184864, 1K0S171480, 3K0S182649, 3K0S185984, 4K0S190521, 4K0S190528, 4K0S190535, 4K0S190536, 4K0S190542, 4K0S192519, 4K0S192525, 4K0S192531, 1K0S172043, 1K0S172193, 2K0S179478, 2K0S179481, 4K0S191585, 4K0S192238, 4K0S192515, 4K0S192524, 3K0S182628, 2K0S179497, 3K0S182630, 3K0S186934, 1K0S171485, 3K0S185733, 3K0S186035, 4K0S192732, 3K0S185731, 1K0S171476, 1K0S172051, 3K0S182653, 3K0S182639, 4K0S192724, 4K0S192726, 1K0S171814, 4K0S190523, 4K0S190854, 4K0S190510, 4K0S191126, 4K0S191127, 1K0S171497, 3K0S182631, 1K0S171827, 3K0S184909, 1K0S171824, 1K0S171826, 1K0S171475, 1K0S171499, 2K0S179480, 2K0S179483, 2K0S180513, 2K0S180519, 3K0S186945, 3K0S186957, 3K0S186936, 3K0S186045, 2K0S181707, 2K0S181712, 2K0S181718, 1K0S171487, 3K0S186940, 3K0S186959, 3K0S185986, 3K0S185991, 4K0S190540, 2K0S180520, 2K0S180532, 2K0S180628, 4K0S190851, 4K0S191587, 3K0S185282, 3K0S186031, 2K0S181714, 3K0S184869, 3K0S184871, 3K0S184873, 3K0S184880, 3K0S184900, 3K0S184904, 3K0S184912, 3K0S184866, 3K0S184876, 3K0S184886, 3K0S184888, 3K0S184896, 3K0S184897, 3K0S184898, 3K0S185993, 3K0S186033, 4K0S192513, 4K0S192535, 4K0S191572, 4K0S190529, 1K0S171833, 1K0S171840, 3K0S185308, 1K0S171849, 1K0S172044, 4K0S192725, 4K0S192529, 2K0S180523, 4K0S191137, 3K0S186937, 3K0S186943, 3K0S186994, 1K0S172196, 1K0S172264, 1K0S172265, 1K0S172183, 1K0S172263, 1K0S171837, 1K0S171493, 1K0S172191, 1K0S172201, 1K0S171489, 1K0S171807, 1K0S172054, 1K0S172194, 1K0S172198, 1K0S171820, 1K0S172205, 1K0S171819, 1K0S171830, 1K0S171486, 1K0S171836, 2K0S179486, 2K0S179492, 2K0S179493, 2K0S179498, 1K0S171812, 1K0S171813, 1K0S171821, 1K0S172048, 1K0S172053, 1K0S172060, 1K0S172179, 1K0S172184, 1K0S172204, 1K0S171847, 1K0S172180, 1K0S172203, 1K0S172195, 1K0S172197, 1K0S171816, 1K0S171835, 1K0S172058, 1K0S172187, 1K0S172199, 3K0S184882, 3K0S184901, 3K0S184883, 3K0S185307, 3K0S185976, 4K0S191138, 4K0S190848, 4K0S191128, 4K0S192521, 3K0S182640, 1K0S171817, 3K0S185980, 3K0S186961, 3K0S186949, 4K0S191513, 1K0S171834, 2K0S179491, 4K0S192733, 4K0S192723.. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2341-2024&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2341-2024&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2341-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-2341-2024 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2341-2024&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2341-2024&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2341-2024/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-2341-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-2341-2024", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Fresenius Medical Care Holdings, Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2024-06-03", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 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"Distribution pattern", "Value": "Domestic: Nationwide Distribution. International: Canada.", "Status": "recorded" } } ] } ] }