Z-1135-2025.jsonld
type: Dataset
name: Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, C…
description: FDA recall Z-1135-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPI…
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: Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, C…
  manufacturer: Cardinal Health 200, LLC
claims: enforcement-record
claims: FDA classified recall Z-1135-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1135-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1135-2025
      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: Cardinal Health 200, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-08
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1) CHIP99SP11, UDI-DI:10195594137595 (each) 50195594137593 (case), Lot Number: 5138229 ; 2) CHIP99SP12, UDI-DI:10195594268466 (each) 50195594268464 (case), Lot Number: 5324036 ; 3) CHIP99SP13, UDI-DI:10197106271377 (each) 50197106271375 (case), Lot Number: 6907769 ; 4) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7045815 ; 5) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280043 ; 6) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701891 ; 7) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701938 ; 8) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6986974 ; 9) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7005449 ; 10) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7055825 ; 11) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7160425 ; 12) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7260062 ; 13) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280062 ; 14) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7287465 ; 15) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485588 ; 16) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7331290 ; 17) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4218Z ; 18) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678H ; 19) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678J ; 20) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332809 ; 21) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678P ; 22) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 23) CHIP99SP1E, UDI-DI:1088843937…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1135-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPIN…
text: The FDA logged enforcement record Z-1135-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog N…
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-1135-2025 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.