Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
type: Dataset
description: FDA recall Z-3138-2024 — CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 - 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 System PC Unit Model 8015 - a modular infusion pump and monitoring system
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-3138-2024: CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
claims: FDA classified recall Z-3138-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3138-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3138-2024
      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: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859 16355147 16385733 16356177 16358090 16405681 16405365 16391644 16365407 16380736 16406383 16370288 16342333 16406520 16340432 16406486 16342209 16339360 16356089 16379852 16406293 16365679 16343510 16340086 16394051 16372192 16406547 16392519 16342393 16370109 16378495 16380421 16406296 16366356 16406474 16376814 16333959 16390881 16355769 16405567 16405941 16380737 16406213 16391082 16405988 16340999 16334088 16370963 16405969 16406245 16406332 16406224 16386484 16406461 16394270 16406295 16381987 16405986 16337357 16405861 16373958 16388828 16406482 16377465 16406473 16378711 16343560 16388488 16384288 16342306 16342387 16355791 16366771 16406518 16398407 16392150 16339100 16339855 16385755 16386553 16360664 16394173 16406317 16388663 16389674 16406471 16390470 16402464 16341647 16365652 16405580 16343049 16390351 16365011 16406536 16406484 16357255 16344098 16405945 16405623 16340058 16381253 16398304 16406479 16405601 16392485 16406540 16374550 16339803 16406524 16377605 16372148 16406514 16406539 16340891 16406457 16339474 16370175 16340358 16406543 16369665 16366663 16341788 16380626 16406511 16406502 16406519 16400608 16405768 16406552 16406517 16405448 16203194 16202076 16202216 16202221 16203212 16202062 16203196 16202042 16203116 16203187 16202205 16203083 16203208 16203198 16202983 16203185 16203120 16202120 16203152 16203200 16203146 16203125 16203149 16203081 16192323 16192072 16192120 16192208 16376983 16358358 16358871 16431754 16344417 16432467 16431907 16507863 16433198 16432477 16433311 16506147 16345129 16433053 16433227 16490382 16431647 16508003 16508095 16506196 16432231 16344327 16431706 16346301 16344250 16506376 16505293 16431887 16504733 16502286 16343587 16467604 16506192 16508094 16508165 16343705 16432864 1643…
      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-3138-2024: CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
type: Claim
text: The FDA logged enforcement record Z-3138-2024: CareFusion 303, Inc. is voluntarily recalling Alaris System PC Unit Model 8015 - 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: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859 16355147 16385733 16356177 16358090 16405681 16405365 16391644 16365407 16380736 16406383 16370288 16342333 16406520 16340432 16406486 16342209 16339360 16356089 16379852 16406293 16365679 16343510 16340086 16394051 16372192 16406547 16392519 16342393 16370109 16378495 16380421 16406296 16366356 16406474 16376814 16333959 16390881 16355769 16405567 16405941 16380737 16406213 16391082 16405988 16340999 16334088 16370963 16405969 16406245 16406332 16406224 16386484 16406461 16394270 16406295 16381987 16405986 16337357 16405861 16373958 16388828 16406482 16377465 16406473 16378711 16343560 16388488 16384288 16342306 16342387 16355791 16366771 16406518 16398407 16392150 16339100 16339855 16385755 16386553 16360664 16394173 16406317 16388663 16389674 16406471 16390470 16402464 16341647 16365652 16405580 16343049 16390351 16365011 16406536 16406484 16357255 16344098 16405945 16405623 16340058 16381253 16398304 16406479 16405601 16392485 16406540 16374550 16339803 16406524 16377605 16372148 16406514 16406539 16340891 16406457 16339474 16370175 16340358 16406543 16369665 16366663 16341788 16380626 16406511 16406502 16406519 16400608 16405768 16406552 16406517 16405448 16203194 16202076 16202216 16202221 16203212 16202062 16203196 16202042 16203116 16203187 16202205 16203083 16203208 16203198 16202983 1620318…
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-3138-2024 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.