Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
type: Dataset
description: FDA recall Z-1139-2023 — Baxter Healthcare Corporation is recalling Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals (Devices, Class I). 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: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
  type: MedicalDevice
  manufacturer: Baxter Healthcare Corporation
claims: FDA recall Z-1139-2023: Baxter Healthcare Corporation is recalling Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
claims: FDA classified recall Z-1139-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1139-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1139-2023
      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 I
      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: Baxter Healthcare Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-01-25
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 120300000056, 120370002035, 120370001529, 120370001518, 120370001514, 120370001909, 120370001971, 120360000581, 120370001980, 120370002002, 120380000643, 120370001975, 120370002042, 120370002030, 120370002105, 120370000385, 120380000419, L1903097-020, L2002011-022, L2002011-007, L2001042-044, 120370002039, 120380000532, 120370002025, 120370001961, 120370002107, 120370000386, 120370002027, 120370002034, 120350000951, 120370001519, 120370002036, 120370002001, 120370002092, 120380000420, 120370001523, 120380000636, 120380000644, 120370002031, 120340000517, 120350000961, 120330000935, 120310001578, 120330000936, 120370001513, L1912025-010, L191025-031, L1904050-005, L1911019-032, L1904050-015, L1912025-041, L1904050-010, L1904038-012, L1904050-007, L1912025-005, L1912025-033, L2001016-048, L2001006-046, L2001044-048, L2001044-043, L1912025-028, L2001006-045, L2001006-032, L2001006-042, 120210000743, L2004034-151, L2004034-142, L1905010-043, L2001042-045, L2005055-715, L2005012-003, L2005055-741, L2003004-081, L2004034-152, 120370002029, L2005055-863, 120340000504, 120370000380, 120310001637, 120350000960, 120370002041, 120370001520, 120370001535, L2006020-362, 120370001524, 120310001642, 120340000333, 120380001660, 120370001979, 120190001262, 120340000546, 120370002024, 120190000713, 120310001668, 120370001525, 120350000947, 120310001015, 120370001530, 120190001263, 120370002033, L2001016-009, L2001016-005, L2001044-038, L2001006-033, L2001006-049, L2001006-012, L2001006-013, L2001006-010, L2001006-026, L2001042-013, L2004034-099, L2003015-100, L2005055-751, L2005055-750, 120210000754, L2002040-058, L2006022-004, L2005055-914, L2005055-962, 120340000524, 120340000535, 120330000931, 120340000542, 120340001031, 120370001536, 120340000539, 120340000533, 120350000967, 120310001131, 120340000303, 120340001022, 120190001272, 120340000547, 120340001046, 120310001657, …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Nationwide
      status: recorded

FDA recall Z-1139-2023: Baxter Healthcare Corporation is recalling Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
type: Claim
text: The FDA logged enforcement record Z-1139-2023: Baxter Healthcare Corporation is voluntarily recalling Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals — reason: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-25. Affected lots/codes: a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 120300000056, 120370002035, 120370001529, 120370001518, 120370001514, 120370001909, 120370001971, 120360000581, 120370001980, 120370002002, 120380000643, 120370001975, 120370002042, 120370002030, 120370002105, 120370000385, 120380000419, L1903097-020, L2002011-022, L2002011-007, L2001042-044, 120370002039, 120380000532, 120370002025, 120370001961, 120370002107, 120370000386, 120370002027, 120370002034, 120350000951, 120370001519, 120370002036, 120370002001, 120370002092, 120380000420, 120370001523, 120380000636, 120380000644, 120370002031, 120340000517, 120350000961, 120330000935, 120310001578, 120330000936, 120370001513, L1912025-010, L191025-031, L1904050-005, L1911019-032, L1904050-015, L1912025-041, L1904050-010, L1904038-012, L1904050-007, L1912025-005, L1912025-033, L2001016-048, L2001006-046, L2001044-048, L2001044-043, L1912025-028, L2001006-045, L2001006-032, L2001006-042, 120210000743, L2004034-151, L2004034-142, L1905010-043, L2001042-045, L2005055-715, L2005012-003, L2005055-741, L2003004-081, L2004034-152, 120370002029, L2005055-863, 120340000504, 120370000380, 120310001637, 120350000960, 120370002041, 120370001520, 120370001535, L2006020-362, 120370001524, 120310001642, 120340000333, 120380001660, 120370001979, 120190001262, 120340000546, 120370002024, 120190000713, 120310001668, 120370001525, 120350000947, 120310001015, 120370001530, 120190001263, 12037000…
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-1139-2023 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.