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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0705-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)\tQS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)\tQS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)\tQS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)\tQS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)\tQS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)\tQS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)\tQS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)\tQS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)\tQS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)\tQS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)\tQS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX:  u)\tQS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB:  v)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA:  w)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA:  x)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA:  y)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA:  z)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA:  aa)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA:  bb)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA:  cc)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA:  dd)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB:  ee)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB:  ff)\tQS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC:  gg)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA:  hh)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA:  ii)\tQS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA:  jj)\tQS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB:  kk)\tQS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX:  ll)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA:  mm)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA:  nn)\tQS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX:  oo)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB:  pp)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB:  qq)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX:  rr)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA:  ss)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX:  tt)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX:  uu)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA:  vv)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA:  ww)\tQS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA:  xx)\tQS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA:  yy)\tQS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB:  zz)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB:  aaa)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB:  bbb)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1:  ccc)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA:  ddd)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA:  eee)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA:  fff)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1:  ggg)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1:  hhh)\tQS6 AM12QKIT  AHA XML / QS-6CC-XXAXA:  iii)\tQS6 AM12QKIT AHA / QS-6CC-XXBXX:  jjj)\tQS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB:  kkk)\tQS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX:  lll)\tQS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX:  mmm)\tQS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX:  nnn)\tQS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA:  ooo)\tQS6 AM12QSYS IEC XML / QS-6CB-CXCXA:  ppp)\tQS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX:  qqq)\tQS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA:  rrr)\tQS6 NOACQMOD KIT  NO LDSET XML / QS-6XC-XXXXA:  sss)\tQS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX:  ttt)\tQS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB:  uuu)\tQS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA:  vvv)\tQS6 PRO ENHANCED SECURITY / QS6-STTDX:  www)",
  "description": "FDA recall Z-0705-2024 — Baxter Healthcare Corporation is recalling Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)\tQS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)\tQS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)\tQS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)\tQS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)\tQS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)\tQS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)\tQS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)\tQS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)\tQS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)\tQS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)\tQS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX:  u)\tQS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB:  v)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA:  w)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA:  x)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA:  y)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA:  z)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA:  aa)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA:  bb)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA:  cc)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA:  dd)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB:  ee)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB:  ff)\tQS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC:  gg)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA:  hh)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA:  ii)\tQS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA:  jj)\tQS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB:  kk)\tQS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX:  ll)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA:  mm)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA:  nn)\tQS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX:  oo)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB:  pp)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB:  qq)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX:  rr)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA:  ss)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX:  tt)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX:  uu)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA:  vv)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA:  ww)\tQS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA:  xx)\tQS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA:  yy)\tQS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB:  zz)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB:  aaa)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB:  bbb)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1:  ccc)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA:  ddd)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA:  eee)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA:  fff)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1:  ggg)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1:  hhh)\tQS6 AM12QKIT  AHA XML / QS-6CC-XXAXA:  iii)\tQS6 AM12QKIT AHA / QS-6CC-XXBXX:  jjj)\tQS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB:  kkk)\tQS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX:  lll)\tQS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX:  mmm)\tQS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX:  nnn)\tQS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA:  ooo)\tQS6 AM12QSYS IEC XML / QS-6CB-CXCXA:  ppp)\tQS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX:  qqq)\tQS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA:  rrr)\tQS6 NOACQMOD KIT  NO LDSET XML / QS-6XC-XXXXA:  sss)\tQS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX:  ttt)\tQS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB:  uuu)\tQS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA:  vvv)\tQS6 PRO ENHANCED SECURITY / QS6-STTDX:  www) (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "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-0705-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)\tQS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)\tQS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)\tQS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)\tQS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)\tQS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)\tQS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)\tQS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)\tQS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)\tQS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)\tQS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)\tQS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX:  u)\tQS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB:  v)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA:  w)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA:  x)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA:  y)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA:  z)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA:  aa)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA:  bb)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA:  cc)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA:  dd)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB:  ee)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB:  ff)\tQS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC:  gg)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA:  hh)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA:  ii)\tQS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA:  jj)\tQS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB:  kk)\tQS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX:  ll)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA:  mm)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA:  nn)\tQS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX:  oo)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB:  pp)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB:  qq)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX:  rr)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA:  ss)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX:  tt)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX:  uu)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA:  vv)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA:  ww)\tQS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA:  xx)\tQS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA:  yy)\tQS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB:  zz)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB:  aaa)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB:  bbb)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1:  ccc)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA:  ddd)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA:  eee)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA:  fff)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1:  ggg)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1:  hhh)\tQS6 AM12QKIT  AHA XML / QS-6CC-XXAXA:  iii)\tQS6 AM12QKIT AHA / QS-6CC-XXBXX:  jjj)\tQS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB:  kkk)\tQS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX:  lll)\tQS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX:  mmm)\tQS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX:  nnn)\tQS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA:  ooo)\tQS6 AM12QSYS IEC XML / QS-6CB-CXCXA:  ppp)\tQS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX:  qqq)\tQS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA:  rrr)\tQS6 NOACQMOD KIT  NO LDSET XML / QS-6XC-XXXXA:  sss)\tQS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX:  ttt)\tQS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB:  uuu)\tQS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA:  vvv)\tQS6 PRO ENHANCED SECURITY / QS6-STTDX:  www)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Baxter Healthcare Corporation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0705-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0705-2024: Baxter Healthcare Corporation is recalling Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)\tQS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)\tQS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)\tQS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)\tQS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)\tQS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)\tQS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)\tQS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)\tQS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)\tQS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)\tQS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)\tQS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX:  u)\tQS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB:  v)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA:  w)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA:  x)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA:  y)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA:  z)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA:  aa)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA:  bb)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA:  cc)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA:  dd)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB:  ee)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB:  ff)\tQS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC:  gg)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA:  hh)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA:  ii)\tQS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA:  jj)\tQS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB:  kk)\tQS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX:  ll)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA:  mm)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA:  nn)\tQS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX:  oo)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB:  pp)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB:  qq)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX:  rr)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA:  ss)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX:  tt)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX:  uu)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA:  vv)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA:  ww)\tQS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA:  xx)\tQS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA:  yy)\tQS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB:  zz)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB:  aaa)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB:  bbb)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1:  ccc)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA:  ddd)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA:  eee)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA:  fff)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1:  ggg)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1:  hhh)\tQS6 AM12QKIT  AHA XML / QS-6CC-XXAXA:  iii)\tQS6 AM12QKIT AHA / QS-6CC-XXBXX:  jjj)\tQS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB:  kkk)\tQS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX:  lll)\tQS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX:  mmm)\tQS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX:  nnn)\tQS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA:  ooo)\tQS6 AM12QSYS IEC XML / QS-6CB-CXCXA:  ppp)\tQS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX:  qqq)\tQS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA:  rrr)\tQS6 NOACQMOD KIT  NO LDSET XML / QS-6XC-XXXXA:  sss)\tQS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX:  ttt)\tQS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB:  uuu)\tQS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA:  vvv)\tQS6 PRO ENHANCED SECURITY / QS6-STTDX:  www)",
      "text": "The FDA logged enforcement record Z-0705-2024: Baxter Healthcare Corporation is voluntarily recalling Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)\tQS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)\tQS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)\tQS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)\tQS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)\tQS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)\tQS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)\tQS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)\tQS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)\tQS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)\tQS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)\tQS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)\tQS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)\tQS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)\tQS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX:  u)\tQS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB:  v)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA:  w)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA:  x)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA:  y)\tQS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA:  z)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA:  aa)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA:  bb)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA:  cc)\tQS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA:  dd)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB:  ee)\tQS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB:  ff)\tQS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC:  gg)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA:  hh)\tQS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA:  ii)\tQS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA:  jj)\tQS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB:  kk)\tQS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX:  ll)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA:  mm)\tQS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA:  nn)\tQS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX:  oo)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB:  pp)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB:  qq)\tQS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX:  rr)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA:  ss)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX:  tt)\tQS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX:  uu)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA:  vv)\tQS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA:  ww)\tQS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA:  xx)\tQS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA:  yy)\tQS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB:  zz)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB:  aaa)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB:  bbb)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1:  ccc)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA:  ddd)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA:  eee)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA:  fff)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1:  ggg)\tQS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1:  hhh)\tQS6 AM12QKIT  AHA XML / QS-6CC-XXAXA:  iii)\tQS6 AM12QKIT AHA / QS-6CC-XXBXX:  jjj)\tQS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB:  kkk)\tQS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX:  lll)\tQS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX:  mmm)\tQS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX:  nnn)\tQS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA:  ooo)\tQS6 AM12QSYS IEC XML / QS-6CB-CXCXA:  ppp)\tQS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX:  qqq)\tQS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA:  rrr)\tQS6 NOACQMOD KIT  NO LDSET XML / QS-6XC-XXXXA:  sss)\tQS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX:  ttt)\tQS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB:  uuu)\tQS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA:  vvv)\tQS6 PRO ENHANCED SECURITY / QS6-STTDX:  www) — reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-08. Affected lots/codes: a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers:  116350524925, 116490541255;  b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers:  119050000134;  c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers:  122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135;  d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers:  123170000019;  e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers:  116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470;  f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers:  116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 116310521231, 116310521175, 116320522055, 116330522666, 116340523645, 116370526300, 116370526302, 116380527090, 116370526980, 116390528637, 116380528395, 116390529243, 116390529244, 116390529289, 116390529290, 116390529245, 116390529246, 116400530260, 116430534181, 116440534647, 116440535722, 116450535995, 116460537454, 116460537582, 116490541890, 116500544101, 116500544003, 116510545088, 116520546283, 116530547307, 116530547308, 116530547309, 116520546501, 116530547394, 117010549346, 117020550273, 117040551450, 117030550903, 117050552567, 117080554660, 117110556288, 117120556595, 117140562002, 117170565229, 117170566105, 117230572559, 117230572529, 117230572792, 117230572972, 117240573048, 117240573453, 117240573579, 117280577601, 117290579316, 117300580356, 117320581836, 117320581837, 117320582120, 117380587062, 117390588108, 117450593979, 117450593976, 117450593977, 117450593978, 117480597797, 117480597798, 117480597583, 117480597584, 117520603269, 117520603562, 118040607784, 118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831;  g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers:  123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329;  h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers:  123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171;  i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers:  123400000592, 123400000593;  j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers:  116120372696;  k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406;   l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers:  116330522481;  m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers:  116070309986;  n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers:  117380586614;  o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers:  116150390529, 116210438777, 116530547233, 116530547234, 116530547235;  p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers:  119470001903;  q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers:  117280578329;  r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers:  117120558685;  s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895;  t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers:  118200636641;  u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers:  123130002242;  v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers:  122060000614, 121270000363, 117210570696;  w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers:  123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565;  x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers:  118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646;  y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers:  122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118;  z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers:  118070613220;  aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers:  123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519;  bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers:  117290578972;  cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers:  117430591575;  dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers:  123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156;  ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers:  119350002685, 119100000503;  ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers:  119350002686;  gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers:  123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611;  hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers:  119350002087, 119100000502;  ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers:  116110349242;  jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers:  122240001151, 120390000393, 118070613221;  kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers:  116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269;  ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers:  119270000108, 119040000856, 117490600126, 123110000500;  mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers:  118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501;  nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers:  116230451701;  oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers:  119240000738, 115510284694;  pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers:  116150390528;  qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers:  116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162;  rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers:  122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629;  ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers:  116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164;  tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers:  116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971, 117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732;  uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers:  118180633960;  vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers:  117140561568;  ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers:  116190425280;  xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers:  116140389770;  yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers:  116170410170;  zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers:  116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 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A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-0705-2024&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-0705-2024&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-0705-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0705-2024 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-0705-2024&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-0705-2024&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-0705-2024/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0705-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0705-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "Baxter Healthcare Corporation",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-12-08",
            "Status": "recorded"
          }
        },
        {
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          "item": {
            "Field": "Lot/code info",
            "Value": "a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers:  116350524925, 116490541255;  b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers:  119050000134;  c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers:  122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135;  d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers:  123170000019;  e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers:  116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470;  f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers:  116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 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118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831;  g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers:  123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329;  h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers:  123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171;  i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers:  123400000592, 123400000593;  j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers:  116120372696;  k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406;   l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers:  116330522481;  m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers:  116070309986;  n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers:  117380586614;  o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers:  116150390529, 116210438777, 116530547233, 116530547234, 116530547235;  p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers:  119470001903;  q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers:  117280578329;  r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers:  117120558685;  s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895;  t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers:  118200636641;  u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers:  123130002242;  v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers:  122060000614, 121270000363, 117210570696;  w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers:  123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565;  x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers:  118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646;  y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers:  122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118;  z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers:  118070613220;  aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers:  123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519;  bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers:  117290578972;  cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers:  117430591575;  dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers:  123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156;  ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers:  119350002685, 119100000503;  ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers:  119350002686;  gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers:  123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611;  hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers:  119350002087, 119100000502;  ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers:  116110349242;  jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers:  122240001151, 120390000393, 118070613221;  kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers:  116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269;  ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers:  119270000108, 119040000856, 117490600126, 123110000500;  mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers:  118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501;  nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers:  116230451701;  oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers:  119240000738, 115510284694;  pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers:  116150390528;  qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers:  116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162;  rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers:  122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629;  ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers:  116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164;  tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers:  116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971, 117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732;  uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers:  118180633960;  vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers:  117140561568;  ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers:  116190425280;  xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers:  116140389770;  yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers:  116170410170;  zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers:  116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 117470596324, 117470596325, 117490599956, 117490599050, 117480597582, 117500600631, 117500600630, 117500600632, 117500600633, 117520603148, 117510602771, 117520603149, 118010605331, 118030607571, 118030607572, 118030607406, 118050609192, 118050609228, 118060610911, 118060610912, 118070613219, 118090615613, 118090615614, 118090615615, 118100617471, 118100617472, 118110618490, 118180634182, 118150627494, 118150627493, 118150627068, 118160628174, 118140626434, 118140626433, 118130624868, 118120622403, 118120622402, 118120622026, 118180634181, 118180635054, 118180635051, 118180635050, 118180634183, 118180635052, 118180635053, 118240001668, 118240001669, 118240001831, 118240001832, 118240001833, 118250001326, 118250001327, 118260000781, 118260000782,  118270000714, 118270000715, 118280001257, 118280001258, 118280001259, 118280001260, 118280001261, 118290000376, 118290000377, 118290000867, 118290001241, 118290001242, 118290001243, 118320001185, 118340000905, 118340000906, 118340000907, 118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 119200001274, 119200001822, 119210001020, 119210001021, 119220000664, 119220000665, 119220001048, 119220001049, 119230002429, 119230002430, 119230002431, 119250000553, 119250001410, 119250001411, 119250001414, 119250001415, 119260000126, 119260000127, 119280001372, 119280001749, 119280001750, 119310000245, 119310000246, 119310000247, 119310000248, 119310001358, 119310001359, 119310001360, 119330000157, 119330000808, 119330000809, 119380001356, 119380001357, 119380001358, 119380001359, 119380001360, 119380001361, 119380001362, 119380001363, 119380001364, 119380001365, 119380001366, 119390001988, 119390001989, 119390001990, 119390000615, 119400000248, 119400000249, 119400000250, 119400000254, 119400000255, 119400001290, 119400001291, 119400001292, 119400001293, 119400001294, 119400001295, 119430001817, 119430001818, 119430001819, 119430001820, 119430001821, 119430001822, 119430001823, 119450001900, 119450001901, 119450001902, 119450001903, 119450001904, 119450001905, 119450001906, 119460001072, 119460001073, 119490000495, 119490000496, 119490000497, 119490000498, 119490000499, 119490000500, 119500000110, 119500000529, 119500000530, 119500000531, 119500000532, 119500000533, 119500001528, 119500001529, 119500001530, 119500001531, 119500001532, 119510000661, 119510000662, 119510000663, 119510000664, 119510000665, 119510001185, 119510001186, 119510001187, 119510001188, 119510001189, 119520000621, 119520000622, 119520000623, 120010000754, 120010000755, 120020001163, 120030000546, 120040000641, 120040000642, 120040000643, 120050000441, 120050000442, 120050000443, 120060000937, 120070001199, 120070001200, 120080000836, 120090001324, 120090001325, 120090001326, 120090001327, 120100000623, 120100000624, 120100000625, 120100000626, 120100001903, 120100001904, 120100001905, 120100001906, 120100001907, 120100001908, 120110002511, 120120000635, 120120000636, 120120000637, 120120000638, 120120001441, 120120001442, 120120001443, 120130000345, 120130000346, 120130000347, 120130001075, 120130001076, 120130001077, 120130001078, 120150002418, 120150002419, 120160001488, 120160001489, 120160001490, 120160001491, 120160001492, 120160001493, 120160001494, 120160001495, 120160001496, 120160001497, 120160001498, 120160001499, 120190000898, 120200001394, 120200001395, 120230001624, 120230001625, 120230001626, 120230002014, 120230002015, 120230002016, 120230002017, 120230002018, 120230002019, 120230002020, 120230002021, 120230002022, 120230002023, 120230002024, 120230002025, 120250000217, 120250000218, 120250000219, 120250000220, 120250000221, 120250000222, 120260000166, 120260000167, 120260000168, 120260000169, 120300000078, 120300001450, 120300001451, 120310001587, 120310001588, 120320000359, 120320000360, 120320000361,",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}