Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
type: Dataset
description: FDA recall Z-3139-2024 — CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120, 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 PCA Module Model 8120, a modular infusion pump and monitoring system
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-3139-2024: CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
claims: FDA classified recall Z-3139-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3139-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3139-2024
      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: 8120 UDI-DI codes: 10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002 Serial Numbers: 16473112 16474187 16458453 16458381 16458632 16472825 16456729 16457626 16453240 16458585 16450364 16459191 16458699 16473046 16458427 16473677 16472463 16459701 16472829 16458736 16458700 16457828 16460132 16455368 16472831 16473116 16457873 16460396 16473618 16473688 16458544 16458121 16473391 16527718 16527910 16441259 16441394 16528387 16441214 16477919 16441048 16525578 16440759 16441453 16525916 16441034 16441160 16441164 16450345 16441601 16454386 16442620 16479558 16452454 16358256 16452960 16453953 16452089 16472866 16452442 16449483 16282569 16452076 16473123 16453256 16448217 16452996 16438128 16453852 16282541 16453263 16453423 16454448 16452576 16450489 16453424 16453702 16453853 16452088 16452445 16453527 16298268 16454345 16282360 16452394 16280503 16452485 16298349 16440752 16441277 16453848 16451983 16453700 16454300 16453421 16438875 16452129 16453535 16452508 16472830 16472480 16442014 16282559 16441295 16450415 16450090 16452417 16471744 16452387 16453522 16453579 16452626 16452536 16282579 16441545 16472995 16282616 16438173 16449362 16449280 16449336 16527580 16441101 16525189 16526900 16526177 16511913 16441474 16515632 16441290 16527326 16440746 16440745 16283136 16284350 16284295 16278278 16282406 16282701 16284376 16284539 16285656 16283024 16285385 16280047 16282941 16282871 16284654 16285713 16280325 16284548 16282671 16284131 16282990 16282603 16285595 16280391 16285788 16285305 16284591 16285009 16280279 16283279 16284313 16285063 16282546 16283207 16282639 16282557 16283012 16284466 16279819 16283281 16282407 16282805 16282548 16284794 16285661 16283272 16282566 16285657 16284238 16285665 16285617 16279174 16283177 16283230 16285241 16282586 16280036 16280501 16284709 16284608 16285706 16285658 16285662 16282640 16282259 16282680 16284959 16284777 16285378 16285693 16279615 16284070 16282678 16…
      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-3139-2024: CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
type: Claim
text: The FDA logged enforcement record Z-3139-2024: CareFusion 303, Inc. is voluntarily recalling Alaris PCA Module Model 8120, 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: 8120 UDI-DI codes: 10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002 Serial Numbers: 16473112 16474187 16458453 16458381 16458632 16472825 16456729 16457626 16453240 16458585 16450364 16459191 16458699 16473046 16458427 16473677 16472463 16459701 16472829 16458736 16458700 16457828 16460132 16455368 16472831 16473116 16457873 16460396 16473618 16473688 16458544 16458121 16473391 16527718 16527910 16441259 16441394 16528387 16441214 16477919 16441048 16525578 16440759 16441453 16525916 16441034 16441160 16441164 16450345 16441601 16454386 16442620 16479558 16452454 16358256 16452960 16453953 16452089 16472866 16452442 16449483 16282569 16452076 16473123 16453256 16448217 16452996 16438128 16453852 16282541 16453263 16453423 16454448 16452576 16450489 16453424 16453702 16453853 16452088 16452445 16453527 16298268 16454345 16282360 16452394 16280503 16452485 16298349 16440752 16441277 16453848 16451983 16453700 16454300 16453421 16438875 16452129 16453535 16452508 16472830 16472480 16442014 16282559 16441295 16450415 16450090 16452417 16471744 16452387 16453522 16453579 16452626 16452536 16282579 16441545 16472995 16282616 16438173 16449362 16449280 16449336 16527580 16441101 16525189 16526900 16526177 16511913 16441474 16515632 16441290 16527326 16440746 16440745 16283136 16284350 16284295 16278278 16282406 16282701 16284376 16284539 16285656 16283024 16285385 16280047 16282941 16282871 16284654 16285713 16280325 16284548 16282671 16284131 16282990 16282603 16285595 16280391 1…
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-3139-2024 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.