Plum Duo Infusion System, List Number: 400020401
type: Dataset
description: FDA recall Z-2129-2025 — ICU Medical, Inc. is recalling Plum Duo Infusion System, List Number: 400020401 (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: Plum Duo Infusion System, List Number: 400020401
  type: MedicalDevice
  manufacturer: ICU Medical, Inc.
claims: FDA recall Z-2129-2025: ICU Medical, Inc. is recalling Plum Duo Infusion System, List Number: 400020401
claims: FDA classified recall Z-2129-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2129-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2129-2025
      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: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-07-11
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: M335400021; Serial Numbers: 50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50002063 50002087 50000125 50004387 50006224 50001628 50003768 50006227 50004720 50005566 50001513 50002064 50002091 50000126 50004389 50006223 50001785 50003775 50006218 50004722 50005572 50001514 50002065 50002107 50000127 50004390 50006220 50002461 50003776 50006205 50004725 50005619 50001515 50002066 50002114 50000128 50004391 50006217 50002491 50003785 50006198 50004726 50005639 50001516 50002067 50002120 50000129 50004392 50006215 50002541 50003786 50006197 50004727 50005663 50001517 50002068 50002123 50000130 50004393 50006214 50002598 50003787 50006183 50004729 50005669 50001518 50002069 50002126 50000131 50004394 50006213 50002599 50003789 50006163 50004730 50005678 50001519 50002070 50002128 50000132 50004395 50006212 50002603 50003793 50006151 50004731 50005680 50001520 50002072 50002143 50000133 50004396 50006211 50002620 50003794 50006150 50004732 50005710 50001521 50002073 50002144 50000134 50004398 50006208 50002627 50003797 50006149 50004733 50005712 50001522 50002074 50002148 50000135 50004399 50006207 50002630 50003798 50006135 50004735 50005730 50001523 50002075 50002149 50000136 50004401 50006206 50002641 50003801 50006133 50004736 50005739 50001524 50002076 50002157 50000137 50004402 50006204 50002650 50003804 50006127 50004737 50005744 50001525 50002077 50002166 50000138 50004403 50006203 50002652 50003807 50006108 50004738 50005781 50001526 50002078 50002174 50000139 50004405 50006202 50002669 50003812 50005275 50004739 50001601 50001527 50002079 50002177 50000140 50004407 50006201 50002673 50003816 50005290 50004740 50001615 50001528 50002080 50002179 50000141 50004409 50006200 50002674 50003817 50005328 50004741 50001651 50001529 50002081 50002183 50000142 50004410 50006199 50002676 50003818 50005360 50004742 50002547 50001530 50002082 50002186 50000143 50004411 50006196 50002679 50003819 50005384 50004744 50002577 50001531 50…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide.
      status: recorded

FDA recall Z-2129-2025: ICU Medical, Inc. is recalling Plum Duo Infusion System, List Number: 400020401
type: Claim
text: The FDA logged enforcement record Z-2129-2025: ICU Medical, Inc. is voluntarily recalling Plum Duo Infusion System, List Number: 400020401 — reason: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-11. Affected lots/codes: UDI-DI: M335400021; Serial Numbers: 50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50002063 50002087 50000125 50004387 50006224 50001628 50003768 50006227 50004720 50005566 50001513 50002064 50002091 50000126 50004389 50006223 50001785 50003775 50006218 50004722 50005572 50001514 50002065 50002107 50000127 50004390 50006220 50002461 50003776 50006205 50004725 50005619 50001515 50002066 50002114 50000128 50004391 50006217 50002491 50003785 50006198 50004726 50005639 50001516 50002067 50002120 50000129 50004392 50006215 50002541 50003786 50006197 50004727 50005663 50001517 50002068 50002123 50000130 50004393 50006214 50002598 50003787 50006183 50004729 50005669 50001518 50002069 50002126 50000131 50004394 50006213 50002599 50003789 50006163 50004730 50005678 50001519 50002070 50002128 50000132 50004395 50006212 50002603 50003793 50006151 50004731 50005680 50001520 50002072 50002143 50000133 50004396 50006211 50002620 50003794 50006150 50004732 50005710 50001521 50002073 50002144 50000134 50004398 50006208 50002627 50003797 50006149 50004733 50005712 50001522 50002074 50002148 50000135 50004399 50006207 50002630 50003798 50006135 50004735 50005730 50001523 50002075 50002149 50000136 50004401 50006206 50002641 50003801 50006133 50004736 50005739 50001524 50002076 50002157 50000137 50004402 50006204 50002650 50003804 50006127 50004737 50005744 50001525 50002077 50002166 50000138 50004403 50006203 50002652 50003807 50006108 50004738 50005781 50001526 50002078 50002174 50000139 50004405 50006202 50002669 50003812 50005275 50004739 50001601 50001527 5000207…
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-2129-2025 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.