2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
type: Dataset
description: FDA recall Z-1870-2024 — Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, 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/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
  type: MedicalDevice
  manufacturer: Fresenius Medical Care Holdings, Inc.
claims: FDA recall Z-1870-2024: Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
claims: FDA classified recall Z-1870-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1870-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1870-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Fresenius Medical Care Holdings, Inc.
      status: recorded
  item list element: 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
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-17
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S271391, 3T0S271405, 3T0S271408, 3T0S271412, 3T0S271423, 3T0S271461, 3T0S271473, 3T0S271474, 3T0S271476, 3T0S271489, 3T0S271490, 3T0S271513, 3T0S271525, 3T0S271533, 1T0S257450, 1T0S257451, 1T0S257452, 1T0S257453, 1T0S257456, 1T0S257458, 1T0S257459, 1T0S257460, 1T0S257461, 1T0S257462, 1T0S257463, 1T0S257464, 1T0S257476, 1T0S257484, 1T0S257493, 1T0S257533, 1T0S257558, 1T0S257562, 1T0S257570, 1T0S257579, 1T0S257583, 1T0S257618, 1T0S257630, 1T0S257648, 1T0S257654, 0T0S251455, 0T0S251464, 0T0S251474, 0T0S251475, 0T0S251480, 2T0S264058, 2T0S264081, 0T0S254168, 0T0S254172, 0T0S254181, 0T0S254193, 0T0S254194, 0T0S254196, 0T0S254200, 0T0S254201, 0T0S254202, 0T0S254203, 0T0S254204, 0T0S254205, 0T0S254208, 0T0S254209, 0T0S254211, 0T0S254212, 0T0S254217, 0T0S254220, 0T0S254234, 1T0S258327, 1T0S258349, 1T0S258356, 1T0S258669, 1T0S258670, 1T0S258672, 1T0S258673, 1T0S258675, 1T0S258679, 1T0S258686, 1T0S258695, 1T0S258699, 1T0S258708, 1T0S258717, 1T0S258722, 1T0S258730, 1T0S260300, 1T0S260303, 1T0S260304, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-1870-2024: Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
type: Claim
text: The FDA logged enforcement record Z-1870-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, 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 2024-04-17. Affected lots/codes: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S271391, 3T0S271405, 3T0S271408, 3T0S271412, 3T0S271423, 3T0S271461, 3T0S271473, 3T0S271474, 3T0S271476, 3T0S271489, 3T0S271490, 3T0S271513, 3T0S271525, 3T0S271533, 1T0S257450, 1T0S257451, 1T0S257452, 1T0S257453, 1T0S257456, 1T0S257458, 1T0S257459, 1T0S257460, 1T0S257461, 1T0S257462, 1T0S257463, 1T0S257464, 1T0S257476, 1T0S257484, 1T0S257493, 1T0S257533, 1T0S257558, 1T0S257562, 1T0S257570, 1T0S257579, 1T0S257583, 1T0S257618, 1T0S257630, 1T0S257648, 1T0S257654, 0T0S251455, 0T0S251464, 0T0S251474, 0T…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-1870-2024 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.