Z-2421-2024.jsonld
type: Dataset
name: CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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-2421-2024 — Smiths Medical ASD Inc. is recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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-2421-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2421-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2421-2024
      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 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI/DI 30610586040430, Serial Numbers: 1024307, 1024333, 1025299, 1027869, 1027794; REF List Number 21-2120-0100-50, UDI/DI 10610586038501, Serial Numbers: 1015104, 1032637, 1019622, 1019666, 1019677, 1019718, 1019720, 1019790, 1019795, 1019806, 1019812, 1019907, 1020978, 1020984, 1021003, 1021146, 1021160, 1021161, 1021229, 1021237, 1021271, 1021285, 1011594, 1011601, 1011616, 1011618, 1011638, 1011640, 1012715, 1012721, 1012726, 1012736, 1021319, 1021382, 1021393, 1023095, 1026455, 1026662, 1026793, 1027760, 1031023, 1031026, 1031696, 1032360, 1032375, 1032377, 1032381, 1032556, 1032560, 1032568, 1032569, 1032570, 1032578, 1032607, 1032633, 1034367, 1034394, 1034411, 1034412, 1034424, 1035087, 1035088, 1035103, 1035105, 1035116, 1032362, 1034083, 1035086, 1128327, 1021322, 1026791, 1034390; REF List Number 21-2120-0102-02, UDI/DI 10610586042591, Serial Numbers: 1074580, 1100001, 1099307, 1099419, 1099421, 1099440; REF List Number 21-2120-0102-03, UDI/DI 10610586042607, Serial Numbers: 1042669, 1055355, 1071360, 1074287, 1076699, 1079688, 1089683, 1054757, 1092499, 1092537, 1092547, 1092561, 1092570, 1094041, 1094824, 1099689, 1099700, 1099712, 1099716, 1099727, 1099732, 1100845, 1101619, 1102930, 1102932, 1103442, 1107615, 1107656, 1108010, 1108016, 1108388, 1113382, 1113411, 1117418, 1117437, 1121537, 1094849, 1108405; REF List Number 21-2120-0102-06, UDI/DI 10610586042614, Serial Numbers: 1037638, 1046463, 1046464, 1108965, 1108983, 1130680; REF List Number 21-2120-0102-51, UDI/DI 10610586042829, Serial Numbers: 1058939, 1040905, 1068036, 1066002, 1114466, 1077271, 1040982, 1077373, 1077404, 1077610, 1077619, 1078365, 1078406, 1078697, 1078714, 1078725, 1108097, 1085482, 1093135, 1085485, 1093180, 1121824, 1107490, 1040654, 1078854, 1096529, 1034466, 1034475, 1034478, 1034482, 1034483, 1034486, 1034488, 1034522, 1034528, 1034533, 1034537, 1034538, 10…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2421-2024: Smiths Medical ASD Inc. is recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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-2421-2024: Smiths Medical ASD Inc. is voluntarily recalling CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI/DI 30610586040430, Serial Numbers: 1024307, 1024333, 1025299, 1027869, 1027794; REF List Number 21-2120-0100-50, UDI/DI 10610586038501, Serial Numbers: 1015104, 1032637, 1019622, 1019666, 1019677, 1019718, 1019720, 1019790, 1019795, 1019806, 1019812, 1019907, 1020978, 1020984, 1021003, 1021146, 1021160, 1021161, 1021229, 1021237, 1021271, 1021285, 1011594, 1011601, 1011616, 1011618, 1011638, 1011640, 1012715, 1012721, 1012726, 1012736, 1021319, 1021382, 1021393, 1023095, 1026455, 1026662, 1026793, 1027760, 1031023, 1031026, 1031696, 1032360, 1032375, 1032377, 1032381, 1032556, 1032560, 1032568, 1032569, 1032570, 1032578, 1032607, 1032633, 1034367, 1034394, 1034411, 1034412, 1034424, 1035087, 1035088, 1035103, 1035105, 1035116, 1032362, 1034083, 1035086, 1128327, 1021322, 1026791, 1034390; REF List Number 21-2120-0102-02, UDI/DI 10610586042591, Serial Numbers: 1074580, 1100001, 1099307, 1099419, 1099421, 1099440; REF List Number 21-2120-0102-03, UDI/DI 10610586042607, Serial Numbers: 1042669, 1055355, 1071360, 1074287, 1076699, 1079688, 1089683, 105475…
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-2421-2024 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.