{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2300-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL",
  "description": "FDA recall Z-2300-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL (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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2300-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2300-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2300-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL",
      "text": "The FDA logged enforcement record Z-2300-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL — reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-15. Affected lots/codes: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ44847I, UPC Number: 019532712755.  b. Model Number: DYNJ82578, UPC Number: 019532719814.  c. Model Number: DYNJ905291B, UPC Number: 019348995037; Model Number: DYNJ905291C, UPC Number: 019532706254.  d. Model Number: DYNJ61957A, UPC Number: 019348969907.  e. Model Number: DYNJ36600F, UPC Number: 088994255256.   f. Model Number: DYNJV0275J, UPC Number: 019348926312; Model Number: DYNJV0275K, UPC Number: 019348926312; Model Number: DYNJV0275L, UPC Number: 019348926312; Model Number: DYNJV0275M, UPC Number: 019532701862.   g. Model Number: DYNJ69682, UPC Number: 019348996892.  h. Model Number: CDS840493F, UPC Number: 019348964363.  i. Model Number: DYNJ24272C, UPC Number: 019348962022.   j. Model Number: DYNJ905290D, UPC Number: 019532706253.  k. Model Number: DYNDC3038, UPC Number: 019348949360.  l. Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491.  m. Model Number: DYNJ83051, UPC Number: 019532724528.  n. Model Number: DYNJ40728D, UPC Number: 019532734836.   o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746.   p. Model Number: DYNJ83462, UPC Number: 019532726814.  q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407.  r. Model Number: DYNJ82570, UPC Number: 019532719806.  s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722.  t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312.  u. Model Number: DYNJ67340, UPC Number: 019348990107.  v. Model Number: DYNJ903457D, UPC Number: 019348967091.  w.  Model Number: DYNJ40077F, UPC Number: 019532717581.  x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551.  y. Model Number: CDS984642, UPC Number: 088438988292.  z. Model Number: DYNJ907339, UPC Number: 019348939732.  aa. Model Number: DYNJ64861A, UPC Number: 019532705363.  bb.  Model Number: DYNJ64862B, UPC Number: 019532705370.  cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543.  dd. Model Number: CDS985384C, UPC Number: 088994296218.  ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293.  ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219.  gg. Model Number: DYNJV0177AG, UPC Number: 019532711235.  hh. Model Number: DYNJV0177AG, UPC Number: 019532711235.   ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571.   jj. Model Number: DYNJ903072R, UPC Number: 019348983405.  kk. Model Number: DYNJ41195D, UPC Number: 019348931425.  ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135.  mm. Model Number: DYNJ66254A, UPC Number: 019348981897.  nn. Model Number: DYNJ59968, UPC Number: 088827779132.  oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757.  pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157.  qq. Model Number: DYNJ905640A, UPC Number: 019532703918.  rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625.  ss. Model Number: DYNJ57646C, UPC Number: 019532728713.   tt. Model Number: DYNJ81369, UPC Number: 019532711530.  uu. Model Number: DYNJ44927F, UPC Number: 019348976680.  vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223.  ww. Model Number: DYNJ57735F, UPC Number: 019348962970.  xx. Model Number: DYNJ59830A, UPC Number: 019348957023.  yy. Model Number: DYNJ62379A, UPC Number: 019532719663.  zz. Model Number: DYNJC9258G, UPC Number: 019532724550.  aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467.  bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827.  ccc. Model Number: DYNJ65710A, UPC Number: 019348993865.  ddd. Model Number: CDS985395D, UPC Number: 019348985971.  eee. Model Number: DYNJ83432, UPC Number: 019532726653.  fff. Model Number: DYNJ64506A, UPC Number: 019348997106.  ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137.  hhh.  Model Number: DYNJ905291C, UPC Number: 019532706254.  iii. Model Number: CDS840493F, UPC Number: 019348964363.  jjj. Model Number: CDS840493F, UPC Number: 019348964363.   kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507.  lll. Model Number: DYNJ69443C, UPC Number: 019532712973.  mmm. Model Number: DYNJ57646B, UPC Number: 019348982850.  nnn. Model Number: DYNJ64964B, UPC Number: 019532707581.  ooo. Model Number: DYNJ59028A, UPC Number: 019348973659.  ppp. Model Number: DYNJ907552A, UPC Number: 019532716605.  qqq. Model Number: DYNJ56904, UPC Number: 088994269345.  rrr. Model Number: DYNJ63209, UPC Number: 019348972788.    sss. Model Number: DYNJ67487B, UPC Number: 019532716614.  ttt. Model Number: DYNJ905495F, UPC Number: 019348992493.  uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026.  vvv. Model Number: DYNJ905884A, UPC Number: 019348979544.  www. Model Number: DYNJ81610, UPC Number: 019532712394.  xxx. Model Number: DYNJ54286A, UPC Number: 088994276549.  yyy. Model Number: CDS984241M, UPC Number: 019532716563.  zzz. Model Number: DYNJ23697N, UPC Number: 019348949845.  aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117.   bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612.   cccc. Model Number: DYNJ48365, UPC Number: 088827759459.   dddd. Model Number: DYNJ69422, UPC Number: 019348993754.   eeee. Model Number: DYNJ905744C, UPC Number: 019532716231.   ffff. Model Number: CDS984764G, UPC Number: 019348945029.   gggg. Model Number: DYNJ81642, UPC Number: 019532712966.   hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392.   iiii. Model Number: DYNJ65048, UPC Number: 019348924286.   jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034.   kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556.   llll. Model Number: DYNJ42976, UPC Number: 088827701914.   mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943.   nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215.   oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127.   pppp. Model Number: DYNJ52024, UPC Number: 088994223335.   qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831.   rrrr. Model Number: DYNJ56235, UPC Number: 088994262155.   ssss. Model Number: DYNJ61247, UPC Number: 019348955170.   tttt. Model Number: DYNJ907552A, UPC Number: 019532716605.   uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219.   vvvv. Model Number: PHS41732B, UPC Number: 019348978481.   wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301.   xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488.   yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921.   zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261.. 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-2300-2023&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-2300-2023&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-2300-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2300-2023 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-2300-2023&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-2300-2023&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-2300-2023/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2300-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2300-2023",
            "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-15",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
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Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491.  m. Model Number: DYNJ83051, UPC Number: 019532724528.  n. Model Number: DYNJ40728D, UPC Number: 019532734836.   o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746.   p. Model Number: DYNJ83462, UPC Number: 019532726814.  q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407.  r. Model Number: DYNJ82570, UPC Number: 019532719806.  s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722.  t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312.  u. Model Number: DYNJ67340, UPC Number: 019348990107.  v. Model Number: DYNJ903457D, UPC Number: 019348967091.  w.  Model Number: DYNJ40077F, UPC Number: 019532717581.  x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551.  y. Model Number: CDS984642, UPC Number: 088438988292.  z. Model Number: DYNJ907339, UPC Number: 019348939732.  aa. Model Number: DYNJ64861A, UPC Number: 019532705363.  bb.  Model Number: DYNJ64862B, UPC Number: 019532705370.  cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543.  dd. Model Number: CDS985384C, UPC Number: 088994296218.  ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293.  ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219.  gg. Model Number: DYNJV0177AG, UPC Number: 019532711235.  hh. Model Number: DYNJV0177AG, UPC Number: 019532711235.   ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571.   jj. Model Number: DYNJ903072R, UPC Number: 019348983405.  kk. Model Number: DYNJ41195D, UPC Number: 019348931425.  ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135.  mm. Model Number: DYNJ66254A, UPC Number: 019348981897.  nn. Model Number: DYNJ59968, UPC Number: 088827779132.  oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757.  pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157.  qq. Model Number: DYNJ905640A, UPC Number: 019532703918.  rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625.  ss. Model Number: DYNJ57646C, UPC Number: 019532728713.   tt. Model Number: DYNJ81369, UPC Number: 019532711530.  uu. Model Number: DYNJ44927F, UPC Number: 019348976680.  vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223.  ww. Model Number: DYNJ57735F, UPC Number: 019348962970.  xx. Model Number: DYNJ59830A, UPC Number: 019348957023.  yy. Model Number: DYNJ62379A, UPC Number: 019532719663.  zz. Model Number: DYNJC9258G, UPC Number: 019532724550.  aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467.  bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827.  ccc. Model Number: DYNJ65710A, UPC Number: 019348993865.  ddd. Model Number: CDS985395D, UPC Number: 019348985971.  eee. Model Number: DYNJ83432, UPC Number: 019532726653.  fff. Model Number: DYNJ64506A, UPC Number: 019348997106.  ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137.  hhh.  Model Number: DYNJ905291C, UPC Number: 019532706254.  iii. Model Number: CDS840493F, UPC Number: 019348964363.  jjj. Model Number: CDS840493F, UPC Number: 019348964363.   kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507.  lll. Model Number: DYNJ69443C, UPC Number: 019532712973.  mmm. Model Number: DYNJ57646B, UPC Number: 019348982850.  nnn. Model Number: DYNJ64964B, UPC Number: 019532707581.  ooo. Model Number: DYNJ59028A, UPC Number: 019348973659.  ppp. Model Number: DYNJ907552A, UPC Number: 019532716605.  qqq. Model Number: DYNJ56904, UPC Number: 088994269345.  rrr. Model Number: DYNJ63209, UPC Number: 019348972788.    sss. Model Number: DYNJ67487B, UPC Number: 019532716614.  ttt. Model Number: DYNJ905495F, UPC Number: 019348992493.  uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026.  vvv. Model Number: DYNJ905884A, UPC Number: 019348979544.  www. Model Number: DYNJ81610, UPC Number: 019532712394.  xxx. Model Number: DYNJ54286A, UPC Number: 088994276549.  yyy. Model Number: CDS984241M, UPC Number: 019532716563.  zzz. Model Number: DYNJ23697N, UPC Number: 019348949845.  aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117.   bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612.   cccc. Model Number: DYNJ48365, UPC Number: 088827759459.   dddd. Model Number: DYNJ69422, UPC Number: 019348993754.   eeee. Model Number: DYNJ905744C, UPC Number: 019532716231.   ffff. Model Number: CDS984764G, UPC Number: 019348945029.   gggg. Model Number: DYNJ81642, UPC Number: 019532712966.   hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392.   iiii. Model Number: DYNJ65048, UPC Number: 019348924286.   jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034.   kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556.   llll. Model Number: DYNJ42976, UPC Number: 088827701914.   mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943.   nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215.   oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127.   pppp. Model Number: DYNJ52024, UPC Number: 088994223335.   qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831.   rrrr. Model Number: DYNJ56235, UPC Number: 088994262155.   ssss. Model Number: DYNJ61247, UPC Number: 019348955170.   tttt. Model Number: DYNJ907552A, UPC Number: 019532716605.   uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219.   vvvv. Model Number: PHS41732B, UPC Number: 019348978481.   wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301.   xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488.   yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921.   zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}