Z-1540-2024.jsonld
type: Dataset
name: Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
description: FDA recall Z-1540-2024 — Smiths Medical ASD Inc. is recalling Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500 (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: MedicalDevice
  name: Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
  manufacturer: Smiths Medical ASD Inc.
claims: enforcement-record
claims: FDA classified recall Z-1540-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1540-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1540-2024
      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: Smiths Medical ASD Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-12-19
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: All serial numbers Medfusion Model 3500 pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a) 3500, UDI/DI NONE, Serial Numbers: M02939, M03874, M09235, M09277, M09440, M09611, M09616, M10171, M10178, M10184, M10211, M10277, M10385, M10621, M11229, M12020, M12026, M12252, M12253, M12254, M13692, M14074, M14737, M15127, M15867, M15889, M16087, M16525, M17236, M17252, M18256, M18273, M18495, M18544, M18589, M18697, M18871, M19131, M21028, M21729, M21739, M22438, M24137, M24448, M28363, M28500, M28504, M30668, M30820, M32347, M36928, M39766; b) 3500-0600-00, UDI/DI 10610586041259, Serial Numbers: M107413, M107445, M107557, M107606, M107707, M107718, M110082, M110289, M110363, M111064, M73212, M-8833, M-8834, M-9284, M-9285, M-9286, M-9301, M-9302, M-9303; c) 3500-0600-01, UDI/DI 10610586041242, Serial Numbers: M100101, M102639, M102877, M103027, M103063, M103064, M103065, M103068, M103093, M103095, M103097, M103098, M103099, M103100, M103101, M103191, M103193, M103203, M103230, M103231, M103232, M103288, M103308, M103309, M103467, M103597, M103598, M103599, M103605, M103608, M103632, M103655, M103656, M103703, M103704, M103705, M103706, M103721, M103777, M103780, M103781, M103852, M103910, M103912, M103913, M103914, M103915, M103917, M103918, M103919, M103920, M103923, M103939, M103965, M103968, M104023, M104031, M104077, M104081, M104082, M104086, M104167, M104168, M104196, M104203, M104214, M104215, M104216, M104224, M104225, M104226, M104227, M104240, M104247, M104250, M104335, M104336, M104340, M104342, M104573, M104574, M104586, M105017, M105388, M105406, M105427, M105494, M105523, M105539, M105546, M105550, M105560, M105563, M105638, M105654, M105661, M105682, M105830, M105893, M105955, M106092, M106254, M106370, M106398, M106403, M106404, M106433, M106457, M106460, M106463, M106506, M106522, M106600, M106604, M106623, M106627, M106628, M106631, M106632, M106659, M106677, M106681, M106715, M106718, M1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1540-2024: Smiths Medical ASD Inc. is recalling Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
text: The FDA logged enforcement record Z-1540-2024: Smiths Medical ASD Inc. is voluntarily recalling Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500 — reason: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-19. Affected lots/codes: All serial numbers Medfusion Model 3500 pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a) 3500, UDI/DI NONE, Serial Numbers: M02939, M03874, M09235, M09277, M09440, M09611, M09616, M10171, M10178, M10184, M10211, M10277, M10385, M10621, M11229, M12020, M12026, M12252, M12253, M12254, M13692, M14074, M14737, M15127, M15867, M15889, M16087, M16525, M17236, M17252, M18256, M18273, M18495, M18544, M18589, M18697, M18871, M19131, M21028, M21729, M21739, M22438, M24137, M24448, M28363, M28500, M28504, M30668, M30820, M32347, M36928, M39766; b) 3500-0600-00, UDI/DI 10610586041259, Serial Numbers: M107413, M107445, M107557, M107606, M107707, M107718, M110082, M110289, M110363, M111064, M73212, M-8833, M-8834, M-9284, M-9285, M-9286, M-9301, M-9302, M-9303; c) 3500-0600-01, UDI/DI 10610586041242, Serial Numbers: M100101, M102639, M102877, M103027, M103063, M103064, M103065, M103068, M103093, M103095, M103097, M103098, M103099, M103100, M103101, M103191, M103193, M103203, M103230, M103231, M103232, M103288, M103308, M103309, M1034…
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-1540-2024 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.