Z-2420-2024.jsonld
type: Dataset
name: CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
description: FDA recall Z-2420-2024 — Smiths Medical ASD Inc. is recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses. (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: MedicalDevice
  name: CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
  manufacturer: Smiths Medical ASD Inc.
claims: enforcement-record
claims: FDA classified recall Z-2420-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2420-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2420-2024
      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 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: Smiths Medical ASD Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-02-27
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 1017146, 1017159, 1017161, 1017163, 1017172, 1017173, 1017174, 1017175, 1017180, 1017189, 1017200, 1017202, 1017221, 1017230, 1017237, 1017241, 1017244, 1017252, 1017261, 1017264, 1017267, 1017276, 1017284, 1017286, 1017290, 1017293, 1017294, 1017295, 1017302, 1017325, 1017327, 1017332, 1017333, 1017339, 1017347, 1017359, 1017407, 1017431, 1017433, 1017435, 1017436, 1017444, 1017447, 1017448, 1017455, 1017463, 1017471, 1017486, 1017488, 1017491, 1017493, 1017508, 1017509, 1017511, 1017512, 1017514, 1017516, 1017518, 1017522, 1017525, 1017532, 1017788, 1017970, 1018001, 1018005, 1018018, 1018048, 1018057, 1018062, 1018095, 1018115, 1018222, 1018286, 1018303, 1018339, 1018376, 1018387, 1018393, 1018415, 1018434, 1018528, 1018538, 1018561, 1018620, 1019029, 1019103, 1019208, 1019262, 1019051, 1020066, 1020067, 1020108, 1020109, 1020110, 1020111, 1020125, 1020128, 1020181, 1020185, 1020197, 1020205, 1020210, 1020221, 1026697, 1026698, 1026702, 1026709, 1026828, 1020836, 1020866, 1021919, 1021943, 1021978, 1022324, 1022…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2420-2024: Smiths Medical ASD Inc. is recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
text: The FDA logged enforcement record Z-2420-2024: Smiths Medical ASD Inc. is voluntarily recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses. — reason: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-27. Affected lots/codes: REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 1017146, 1017159, 1017161, 1017163, 1017172, 1017173, 1017174, 1017175, 1017180, 1017189, 1017200, 1017202, 1017221, 1017230, 1017237, 1017241, 1017244, 1017252, 1017261, 1017264, 1017267, 1017276, 1017284, 1017286, 1017290, 1017293, 1017294, 1017295…
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-2420-2024 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.