Z-2448-2024.jsonld
type: Dataset
name: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set
description: FDA recall Z-2448-2024 — ICU Medical Inc is recalling Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set (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: MedicalDevice
  name: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set
  manufacturer: ICU Medical Inc
claims: enforcement-record
claims: FDA classified recall Z-2448-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2448-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2448-2024
      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 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: ICU Medical Inc
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-05-07
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561, 18077621, 18077674, 18077677, 18077701, 18077737, 18077794, 18077797, 18077824, 18077831, 18077897, 18077941, 18077977, 18078084, 18078101, 18078141, 18078147, 18078151). 2. Product Code: 207920425. No UDI Number (Serial Numbers: 17738835, 17738841, 17738890, 17738893, 17738894, 17738897, 17738898, 17738899, 17738900, 17738901, 17738903, 17738906, 17738911, 17738915, 17738916, 17738918, 17738919, 17738920, 17738921, 17738922, 17738923, 17738925, 17738926, 17738928, 17738930, 17738931, 17738932, 17738933, 17738934, 17738935, 17738936, 17738944, 17738949, 17738953, 17739019, 17739119, 17739125, 17739127, 17739128, 17739130, 17739132, 17739135, 17739137, 17739140, 17739143, 17739145, 17739148, 17739151, 17739160, 17739161, 17739163, 17739164, 17739165, 17739166, 17739168, 17739174, 17739176, 17739180, 17739182, 17739184, 17739185, 17739186, 17739187, 17740923, 17743586, 17749108, 17749143, 17749569, 17749760, 17749803, 17749829, 17750043, 17750610, 17750658, 17750715, 17753103, 17753259, 17753640, 17753665, 17753918, 17753934, 17753935, 17754024, 17754042, 17754098, 17754276, 17754307, 17754387, 17754499, 17754525, 17754531, 17754565, 17754568, 17754577, 17754631, 17754780, 17754838, 17754882, 17755139, 17755145, 17756153, 17756171, 17756203, 17756242, 17756312, 17756315, 17756322, 17756323, 17756325, 17756326, 17756327, 17756328, 17756329, 17756332, 17756333, 17756334, 17756335, 17756338, 17756340, 17756344, 17756345, 17756347, 17756348, 17756349, 17756356, 17756363, 17756364, 17756365, 17756371, 17756379, 17756382, 17756394, 17756402, 17756405, 17756406, 17756408, 17756410, 17756411, 17756412, 17756413, 17756417, 17756418, 17756420, 17756421, 17756424, 17756425, 17756430, 17756453, 17756457, 17756472, 17756477, 17756484, 17756487, 17756488, 17756497, 17756502, 17756506, 17756509, 17756516, 17756517, 17756518, 17756519, 17756520, 17756521, 17756525, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2448-2024: ICU Medical Inc is recalling Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set
text: The FDA logged enforcement record Z-2448-2024: ICU Medical Inc is voluntarily recalling Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set — reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-07. Affected lots/codes: 1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561, 18077621, 18077674, 18077677, 18077701, 18077737, 18077794, 18077797, 18077824, 18077831, 18077897, 18077941, 18077977, 18078084, 18078101, 18078141, 18078147, 18078151). 2. Product Code: 207920425. No UDI Number (Serial Numbers: 17738835, 17738841, 17738890, 17738893, 17738894, 17738897, 17738898, 17738899, 17738900, 17738901, 17738903, 17738906, 17738911, 17738915, 17738916, 17738918, 17738919, 17738920, 17738921, 17738922, 17738923, 17738925, 17738926, 17738928, 17738930, 17738931, 17738932, 17738933, 17738934, 17738935, 17738936, 17738944, 17738949, 17738953, 17739019, 17739119, 17739125, 17739127, 17739128, 17739130, 17739132, 17739135, 17739137, 17739140, 17739143, 17739145, 17739148, 17739151, 17739160, 17739161, 17739163, 17739164, 17739165, 17739166, 17739168, 17739174, 17739176, 17739180, 17739182, 17739184, 17739185, 17739186, 17739187, 17740923, 17743586, 17749108, 17749143, 17749569, 17749760, 17749803, 17749829, 17750043, 17750610, 17750658, 17750715, 17753103, 17753259, 17753640, 17753665, 17…
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-2448-2024 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.