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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2200-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;",
  "description": "FDA recall Z-2200-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A; (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
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    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2200-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2200-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2200-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;",
      "text": "The FDA logged enforcement record Z-2200-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A; — reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: All lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892;  b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864;  c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939;  d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526;  e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310;  f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088;  g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421;  h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659;  i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983;  j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679;  k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249;  l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458;  m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542;  n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805;  o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823;  p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412;  q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429;  r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060;  s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957;  t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233;  u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777;  v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667;  w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338;  x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145;  y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628;  z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337;  aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184;  bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238;  cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115;  dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845;  ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494;  ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811;  gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555;  hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2200-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2200-2023&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2200-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2200-2023 as Class II",
      "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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2200-2023&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2200-2023&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2200-2023/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
  ],
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      "name": "FDA recall details — Z-2200-2023",
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            "Value": "Z-2200-2023",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892;  b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864;  c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939;  d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526;  e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310;  f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088;  g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421;  h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659;  i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983;  j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679;  k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249;  l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458;  m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542;  n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805;  o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823;  p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412;  q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429;  r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060;  s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957;  t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233;  u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777;  v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667;  w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338;  x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145;  y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628;  z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337;  aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184;  bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238;  cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115;  dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845;  ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494;  ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811;  gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555;  hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}