2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
type: Dataset
description: FDA recall Z-1868-2024 — Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191126 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 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
  type: MedicalDevice
  manufacturer: Fresenius Medical Care Holdings, Inc.
claims: FDA recall Z-1868-2024: Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
claims: FDA classified recall Z-1868-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1868-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1868-2024
      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: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 4T0S275745, 4T0S275760, 4T0S275768, 4T0S275769, 4T0S275778, 4T0S275787, 4T0S275800, 4T0S275804, 4T0S276804, 4T0S276814, 4T0S276818, 4T0S276829, 4T0S276833, 4T0S276838, 4T0S276858, 4T0S276867, 4T0S276870, 3T0S269793, 3T0S269826, 3T0S269827, 3T0S269828, 3T0S269836, 3T0S269838, 3T0S269841, 3T0S269842, 3T0S269954, 3T0S269955, 3T0S269956, 3T0S269957, 3T0S269959, 3T0S269960, 3T0S269961, 3T0S269963, 3T0S269964, 3T0S269965, 3T0S269966, 3T0S269968, 3T0S269972, 3T0S269976, 3T0S269978, 3T0S269979, 0T0S253172, 0T0S253178, 0T0S253179, 0T0S253184, 0T0S253188, 0T0S253190, 0T0S253203, 0T0S253208, 0T0S253215, 0T0S253217, 0T0S253222, 0T0S253223, 0T0S253227, 0T0S253230, 0T0S253231, 0T0S253232, 0T0S253240, 0T0S253245, 0T0S253257, 0T0S253268, 0T0S253271, 0T0S253272, 0T0S253286, 1T0S260028, 1T0S260091, 1T0S261521, 1T0S261526, 1T0S261527, 1T0S261536, 1T0S261556, 1T0S261557, 1T0S261558, 1T0S261559, 1T0S261572, 1T0S261573, 1T0S261578, 1T0S261581, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-1868-2024: Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
type: Claim
text: The FDA logged enforcement record Z-1868-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling 2008T BlueStar Hemodialysis Machine, Model 191126 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: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 4T0S275745, 4T0S275760, 4T0S275768, 4T0S275769, 4T0S275778, 4T0S275787, 4T0S275800, 4T0S275804, 4T0S276804, 4T0S276814, 4T0S276818, 4T0S276829, 4T0S276833, 4T0S276838, 4T0S276858, 4T0S276867, 4T0S276870, 3T0S269793, 3T0S269826, 3T0S269827, 3T0S269828, 3T0S269836, 3T0S269838, 3T0S269841, 3T0S269842, 3T0S269954, 3T0S269955, 3T0S269956, 3T0S269957, 3T0S269959, 3T0S269960, 3T0S269961, 3T0S269963, 3T0S269964, 3T0S269965, 3T0S269966, 3…
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-1868-2024 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.