Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
type: Dataset
description: FDA recall Z-3141-2024 — CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110, 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 Syringe Module Model 8110, a modular infusion pump and monitoring system
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-3141-2024: CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
claims: FDA classified recall Z-3141-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3141-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3141-2024
      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: 8110 UDI-DI codes: 10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267 Serial Numbers: 16557517 16557523 16558377 16558030 16557553 16552258 16558259 16555767 16557678 16557941 16557706 16557760 16201478 16204104 16201486 16207089 16204181 16201491 16201552 16206906 16203916 16201484 16201546 16203885 16201616 16207145 16201496 16201611 16206327 16204189 16203959 16206827 16204092 16206937 16206843 16201523 16201556 16206381 16206138 16204129 16205794 16204207 16201166 16201493 16204172 16201517 16201564 16204027 16206473 16207211 16204173 16203733 16206915 16206904 16201480 16201489 16201498 16201623 16201481 16201163 16206319 16201540 16201528 16201156 16201479 16206787 16206311 16206911 16206331 16307400 16294280 16374263 16307376 16373254 16307505 16306734 16306695 16306293 16305549 16306102 16306495 16306346 16305864 16307132 16305897 16307421 16306782 16412939 16306691 16304540 16305993 16306144 16306724 16307095 16307238 16307031 16306324 16306731 16307165 16307138 16305383 16307094 16307005 16306282 16307215 16306544 16307163 16306844 16306988 16305863 16306783 16306258 16307479 16304883 16306852 16307378 16307136 16306866 16307049 16306903 16305010 16306952 16307091 16304922 16307389 16294173 16306250 16307508 16306530 16305266 16305361 16306912 16307024 16305985 16307310 16306915 16305918 16408571 16424860 16428232 16395865 16419208 16422463 16396350 16405652 16411508 16405759 16410726 16431523 16382647 16410597 16422523 16439410 16373945 16411646 16411066 16410949 16410907 16403520 16423002 16407865 16432538 16393069 16409977 16393160 16402880 16396905 16405607 16374597 16411456 16410487 16393153 16410863 16395368 16423835 16409770 16410596 16374504 16390987 16410035 16410547 16405544 16404277 16422875 16395644 16393161 16438985 16393101 16406629 16408211 16424706 16391065 16395742 16374980 16409586 16420098 16374521 16396300 16408068 16393207 16409358 16405322 16409399 16405642 16408611 16405583 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-3141-2024: CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
type: Claim
text: The FDA logged enforcement record Z-3141-2024: CareFusion 303, Inc. is voluntarily recalling Alaris Syringe Module Model 8110, 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: 8110 UDI-DI codes: 10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267 Serial Numbers: 16557517 16557523 16558377 16558030 16557553 16552258 16558259 16555767 16557678 16557941 16557706 16557760 16201478 16204104 16201486 16207089 16204181 16201491 16201552 16206906 16203916 16201484 16201546 16203885 16201616 16207145 16201496 16201611 16206327 16204189 16203959 16206827 16204092 16206937 16206843 16201523 16201556 16206381 16206138 16204129 16205794 16204207 16201166 16201493 16204172 16201517 16201564 16204027 16206473 16207211 16204173 16203733 16206915 16206904 16201480 16201489 16201498 16201623 16201481 16201163 16206319 16201540 16201528 16201156 16201479 16206787 16206311 16206911 16206331 16307400 16294280 16374263 16307376 16373254 16307505 16306734 16306695 16306293 16305549 16306102 16306495 16306346 16305864 16307132 16305897 16307421 16306782 16412939 16306691 16304540 16305993 16306144 16306724 16307095 16307238 16307031 16306324 16306731 16307165 16307138 16305383 16307094 16307005 16306282 16307215 16306544 16307163 16306844 16306988 16305863 16306783 16306258 16307479 16304883 16306852 16307378 16307136 16306866 16307049 16306903 16305010 16306952 16307091 16304922 16307389 16294173 16306250 16307508 16306530 16305266 16305361 16306912 16307024 16305985 16307310 16306915 16305918 16408571 16424860 16428232 16395865 16419208 16422463 16396350 16405652 16411508 16405759 16410726 16431523 16382647 16410597 16422523 16439410 16373945 16411646 16411066 164109…
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-3141-2024 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.