Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
type: Dataset
description: FDA recall Z-3142-2024 — CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100, a modular infusion pump and monitoring system (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: Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-3142-2024: CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
claims: FDA classified recall Z-3142-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3142-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3142-2024
      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: CareFusion 303, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-08-15
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model Number: 8100 UDI-DI code: 10885403810046, 10885403810039, 10885403810015 Serial Numbers: 16448779 16451711 16451209 16450973 16450971 16451760 16407678 16411676 16388896 16405467 16408857 16387206 16405786 16407463 16410819 16407769 16399159 16410420 16411470 16409931 16409006 16411571 16409107 16388799 16472492 16409660 16410466 16404846 16409933 16410968 16406453 16406013 16408309 16402653 16410415 16411500 16411069 16407539 16410537 16451801 16450922 16451705 16448898 16451601 16448918 16450847 16453708 16451857 16451608 16451642 16372116 16451808 16451067 16451690 16451895 16445957 16453760 16451083 16453750 16448376 16450498 16451078 16448899 16451051 16453718 16450801 16449025 16450557 16453778 16448576 16450674 16451410 16448921 16451745 16451356 16451907 16453721 16451788 16450769 16451819 16448338 16449113 16451236 16450609 16450928 16448781 16451823 16450969 16451794 16451840 16451856 16445998 16451321 16451787 16444660 16407683 16410698 16410619 16403032 16472342 16408257 16384862 16407887 16408415 16409022 16406455 16409686 16411724 16410412 16565972 16387963 16409990 16411378 16407898 16409960 16403700 16407660 16389103 16472045 16405794 16409501 16410040 16409063 16410492 16407922 16405757 16410823 16410875 16410360 16410960 16403230 16411134 16409981 16408763 16330176 16389104 16410530 16408195 16407470 16407516 16451525 16453706 16453685 16450810 16448629 16454181 16451518 16451924 16451683 16450580 16451470 16374696 16450837 16450974 16445414 16451618 16449185 16451580 16450851 16442339 16450878 16451817 16448878 16452497 16451578 16453712 16453723 16449014 16453761 16453716 16451827 16451762 16448501 16450869 16450750 16451633 16451780 16446661 16451640 16451656 16451803 16451777 16448664 16448869 16450651 16451804 16450602 16451816 16453689 16451900 16451929 16450936 16451850 16451641 16450819 16451620 16451809 16448315 16453731 16451077 16451782 16451076 16449143 16448926 16453695 16449026 16451852 16448886 16450673 16451659 16442380 164488…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
      status: recorded

FDA recall Z-3142-2024: CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
type: Claim
text: The FDA logged enforcement record Z-3142-2024: CareFusion 303, Inc. is voluntarily recalling Alaris Pump Module Model 8100, a modular infusion pump and monitoring system — reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-15. Affected lots/codes: Model Number: 8100 UDI-DI code: 10885403810046, 10885403810039, 10885403810015 Serial Numbers: 16448779 16451711 16451209 16450973 16450971 16451760 16407678 16411676 16388896 16405467 16408857 16387206 16405786 16407463 16410819 16407769 16399159 16410420 16411470 16409931 16409006 16411571 16409107 16388799 16472492 16409660 16410466 16404846 16409933 16410968 16406453 16406013 16408309 16402653 16410415 16411500 16411069 16407539 16410537 16451801 16450922 16451705 16448898 16451601 16448918 16450847 16453708 16451857 16451608 16451642 16372116 16451808 16451067 16451690 16451895 16445957 16453760 16451083 16453750 16448376 16450498 16451078 16448899 16451051 16453718 16450801 16449025 16450557 16453778 16448576 16450674 16451410 16448921 16451745 16451356 16451907 16453721 16451788 16450769 16451819 16448338 16449113 16451236 16450609 16450928 16448781 16451823 16450969 16451794 16451840 16451856 16445998 16451321 16451787 16444660 16407683 16410698 16410619 16403032 16472342 16408257 16384862 16407887 16408415 16409022 16406455 16409686 16411724 16410412 16565972 16387963 16409990 16411378 16407898 16409960 16403700 16407660 16389103 16472045 16405794 16409501 16410040 16409063 16410492 16407922 16405757 16410823 16410875 16410360 16410960 16403230 16411134 16409981 16408763 16330176 16389104 16410530 16408195 16407470 16407516 16451525 16453706 16453685 16450810 16448629 16454181 16451518 16451924 16451683 16450580 16451470 16374696 16450837 16450974 16445414 16451618 16449185 16451580 16450851 16442339 16450878 16451817 1644…
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-3142-2024 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.