Z-0507-2025.jsonld
type: Dataset
name: V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
description: FDA recall Z-0507-2025 — KCI USA, INC. is recalling V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. (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: V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
  manufacturer: KCI USA, INC.
claims: enforcement-record
claims: FDA classified recall Z-0507-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0507-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0507-2025
      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: KCI USA, INC.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-05
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257 GAAC06258 GAAC06259 GAAC06260 GAAC06261 GAAC06262 GAAC06263 GAAC06264 GAAC06265 GAAC06266 GAAC06267 GAAC06268 GAAC06269 GAAC06270 GAAC06271 GAAC06272 GAAC06273 GAAC06274 GAAC06275 GAAC06276 GAAC06277 GAAC06278 GAAC06279 GAAC06280 GAAC06281 GAAC06282 GAAC06283 GAAC06284 GAAC06285 GAAC06286 GAAC06287 GAAC06288 GAAC06289 GAAC06290 GAAC06291 GAAC06292 GAAC06293 GAAC06294 GAAC06295 GAAC06296 GAAC06297 GAAC06298 GAAC06299 GAAC06300 GAAC06301 GAAC06302 GAAC06303 GAAC06304 GAAC06305 GAAC06306 GAAC06307 GAAC06308 GAAC06309 GAAC06310 GAAC06311 GAAC06312 GAAC06313 GAAC06314 GAAC06315 GAAC06316 GAAC06317 GAAC06318 GAAC06319 GAAC06320 GAAC06321 GAAC06322 GAAC06323 GAAC06324 GAAC06863 GAAC06864 GAAC06865 GAAC06866 GAAC06867 GAAC06868 GAAC06869 GAAC06870 GAAC06871 GAAC06872 GAAC06873 GAAC06874 GAAC06875 GAAC06876 GAAC06877 GAAC06878 GAAC06879 GAAC06880 GAAC06881 GAAC06882 GAAC06883 GAAC06884 GAAC06885 GAAC06886 GAAC06887 GAAC06888 GAAC06889 GAAC06890 GAAC06891 GAAC06892 GAAC06893 GAAC06894 GAAC06895 GAAC06896 GAAC06897 GAAC06898 GAAC06899 GAAC06900 GAAC06901 GAAC06902 GAAC06903 GAAC06904 GAAC06905 GAAC06906 GAAC06907 GAAC06908 GAAC06909 GAAC06910 GAAC06911 GAAC06912 GAAC06913 GAAC06914 GAAC06915 GAAC06916 GAAC06917 GAAC06918 GAAC06919 GAAC06920 GAAC06921 GAAC06922 GAAC06923 GAAC06924 GAAC06925 GAAC06926 GAAC06927 GAAC06928 GAAC06929 GAAC06930 GAAC06931 GAAC06932 GAAC06933 GAAC06934 GAAC06935 GAAC06936 GAAC06937 GAAC06938 GAAC06939 GAAC06940 GAAC06941 GAAC06942 GAAC06943 GAAC06944 GAAC06945 GAAC06946 GAAC06947 GAAC06948 GAAC06949 GAAC06950 GAAC06951 GAAC06952 GAAC06953 GAAC06954 GAAC06955 GAAC06956 GAAC06957 GAAC06958 GAAC11856 GAAC11857 GAAC11858 GAAC11859 GAAC11860 GAAC11861 GAAC11862 GAAC11863 GAAC11864 GAAC11865 GAAC11866 GAAC11867 GAAC11868 GAAC…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania, Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand, South Africa, Vietnam, and Denmark
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0507-2025: KCI USA, INC. is recalling V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
text: The FDA logged enforcement record Z-0507-2025: KCI USA, INC. is voluntarily recalling V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. — reason: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-05. Affected lots/codes: Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257 GAAC06258 GAAC06259 GAAC06260 GAAC06261 GAAC06262 GAAC06263 GAAC06264 GAAC06265 GAAC06266 GAAC06267 GAAC06268 GAAC06269 GAAC06270 GAAC06271 GAAC06272 GAAC06273 GAAC06274 GAAC06275 GAAC06276 GAAC06277 GAAC06278 GAAC06279 GAAC06280 GAAC06281 GAAC06282 GAAC06283 GAAC06284 GAAC06285 GAAC06286 GAAC06287 GAAC06288 GAAC06289 GAAC06290 GAAC06291 GAAC06292 GAAC06293 GAAC06294 GAAC06295 GAAC06296 GAAC06297 GAAC06298 GAAC06299 GAAC06300 GAAC06301 GAAC06302 GAAC06303 GAAC06304 GAAC06305 GAAC06306 GAAC06307 GAAC06308 GAAC06309 GAAC06310 GAAC06311 GAAC06312 GAAC06313 GAAC06314 GAAC06315 GAAC06316 GAAC06317 GAAC06318 GAAC06319 GAAC06320 GAAC06321 GAAC06322 GAAC06323 GAAC06324 GAAC06863 GAAC06864 GAAC06865 GAAC06866 GAAC06867 GAAC06868 GAAC06869 GAAC06870 GAAC06871 GAAC06872 GAAC06873 GAAC06874 GAAC06875 GAAC06876 GAAC06877 GAAC06878 GAAC06879 GAAC06880 GAAC06881 GAAC06882 GAAC06883 GAAC06884 GAAC06885 GAAC06886 GAAC06887 GAAC06888 GAAC06889 GAAC06890 GAAC06891 GAAC06892 GAAC06893 GAAC06894 GAAC06895 GAAC06896 GAAC06897 GAAC06898 GAAC06899 GAAC06900 GAAC06901 GAAC06902 GAAC06903 GAAC06904 GAAC06905 GAAC06906 GAAC06907 GAAC06908 GAAC06909 GAAC06910 GAAC06911 GAAC06912 GAAC06913 GAAC06914 GAAC06915 GAAC06916 GAAC06917 GAA…
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-0507-2025 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.