{
  "@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-2297-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;   p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075;   q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055;   r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US;   t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;   u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470;   v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170;   w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545;   x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B;   y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350;   z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;   aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475;   bb.  7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770;   cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370;   dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910;   ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905;   ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795;   gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705;   hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355;   ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640;   jj. ABLATION EP PACK, Model Number: DYNJ43851B;   kk. ABLATION PACK, Model Number: DYNJ40629C;   ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N;   mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B;   nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S;   oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X;   pp. ANGIO CATH PACK, Model Number: DYNJ52000B;   qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J;   rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F;   ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D;   tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951;   uu. ANGIO PACK-LF, Model Number: DYNJ0407399P;   vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944;   ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A;   xx. ANGIO/PICC PACK, Model Number: DYNJ36049A;   yy. ANGIOGRAM, Model Number: DYNJ0149444N;   zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A;   aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G;   bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A;   ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V;   ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J;   eee",
  "description": "FDA recall Z-2297-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;   p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075;   q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055;   r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US;   t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;   u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470;   v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170;   w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545;   x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B;   y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350;   z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;   aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475;   bb.  7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770;   cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370;   dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910;   ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905;   ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795;   gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705;   hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355;   ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640;   jj. ABLATION EP PACK, Model Number: DYNJ43851B;   kk. ABLATION PACK, Model Number: DYNJ40629C;   ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N;   mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B;   nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S;   oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X;   pp. ANGIO CATH PACK, Model Number: DYNJ52000B;   qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J;   rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F;   ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D;   tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951;   uu. ANGIO PACK-LF, Model Number: DYNJ0407399P;   vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944;   ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A;   xx. ANGIO/PICC PACK, Model Number: DYNJ36049A;   yy. ANGIOGRAM, Model Number: DYNJ0149444N;   zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A;   aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G;   bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A;   ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V;   ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J;   eee (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-2297-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;   p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075;   q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055;   r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US;   t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;   u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470;   v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170;   w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545;   x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B;   y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350;   z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;   aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475;   bb.  7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770;   cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370;   dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910;   ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905;   ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795;   gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705;   hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355;   ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640;   jj. ABLATION EP PACK, Model Number: DYNJ43851B;   kk. ABLATION PACK, Model Number: DYNJ40629C;   ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N;   mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B;   nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S;   oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X;   pp. ANGIO CATH PACK, Model Number: DYNJ52000B;   qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J;   rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F;   ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D;   tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951;   uu. ANGIO PACK-LF, Model Number: DYNJ0407399P;   vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944;   ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A;   xx. ANGIO/PICC PACK, Model Number: DYNJ36049A;   yy. ANGIOGRAM, Model Number: DYNJ0149444N;   zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A;   aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G;   bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A;   ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V;   ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J;   eee",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2297-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2297-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;   p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075;   q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055;   r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US;   t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;   u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470;   v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170;   w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545;   x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B;   y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350;   z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;   aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475;   bb.  7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770;   cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370;   dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910;   ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905;   ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795;   gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705;   hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355;   ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640;   jj. ABLATION EP PACK, Model Number: DYNJ43851B;   kk. ABLATION PACK, Model Number: DYNJ40629C;   ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N;   mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B;   nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S;   oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X;   pp. ANGIO CATH PACK, Model Number: DYNJ52000B;   qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J;   rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F;   ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D;   tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951;   uu. ANGIO PACK-LF, Model Number: DYNJ0407399P;   vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944;   ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A;   xx. ANGIO/PICC PACK, Model Number: DYNJ36049A;   yy. ANGIOGRAM, Model Number: DYNJ0149444N;   zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A;   aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G;   bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A;   ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V;   ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J;   eee",
      "text": "The FDA logged enforcement record Z-2297-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;   p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075;   q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055;   r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US;   t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;   u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470;   v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170;   w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545;   x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B;   y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350;   z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;   aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475;   bb.  7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770;   cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370;   dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910;   ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905;   ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795;   gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705;   hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355;   ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640;   jj. ABLATION EP PACK, Model Number: DYNJ43851B;   kk. ABLATION PACK, Model Number: DYNJ40629C;   ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N;   mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B;   nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S;   oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X;   pp. ANGIO CATH PACK, Model Number: DYNJ52000B;   qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J;   rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F;   ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D;   tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951;   uu. ANGIO PACK-LF, Model Number: DYNJ0407399P;   vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944;   ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A;   xx. ANGIO/PICC PACK, Model Number: DYNJ36049A;   yy. ANGIOGRAM, Model Number: DYNJ0149444N;   zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A;   aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G;   bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A;   ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V;   ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J;   eee — 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: DYNJ908249A, UPC Number: 019532724050.  b. Model Number: ECVC7410A, UPC Number: 10653160353645.   c. Model Number: ECVC2205A, UPC Number: 10653160357148.   d. Model Number: ECVC8095, UPC Number: 10653160357759.   e. Model Number: ECVC5010A, UPC Number: 10653160335290.   f. Model Number: ECVC6800A, UPC Number: 10653160355694.   g. Model Number: ECVC2555, UPC Number: 10653160336570.   h. Model Number: ECVC4125, UPC Number: 10653160339502.   i. Model Number: ECVC5135B, UPC Number: 10653160353652.   j. Model Number: ECVC7325, UPC Number: 10653160345589.   k. Model Number: ECVC1970B, UPC Number: 10653160357155.   l. Model Number: ECVC4335, UPC Number: 10653160357285.   m. Model Number: ECVC7160, UPC Number: 10653160335306.    n. Model Number: ECVC2560, UPC Number: 10653160334286.     o. Model Number: ECVC3505, UPC Number: 10653160334767.   p. Model Number: ECVC7075, UPC Number: 10653160335122.   q. Model Number: ECVC8055, UPC Number: 10653160355656.   r. Model Number: ECVC8165, UPC Number: 10653160358749.   s. Model Number: ECVC4635A, UPC Number: 10653160352112; Model Number: ECVC7040A, UPC Number: 10653160344414; Model Number: ECVC7430, UPC Number: 10653160346524; Model Number: ECVC7475, UPC Number: 10653160347569; Model Number: ECVC7605, UPC Number: 10653160347743; Model Number: ECVC7675, UPC Number: 10653160348122; Model Number: ECVC8005, UPC Number: 10653160355137; Model Number: ECVC8130, UPC Number: 10653160358343; Model Number: STCVC2055US, UPC Number: 10653160355564.   t. Model Number: ECVC7600, UPC Number: 10653160347736.   u. Model Number: ECVC4640A, UPC Number: 10653160352105; Model Number: ECVC6490A, UPC Number: 10653160344360; Model Number: ECVC6845, UPC Number: 10653160339366; Model Number: ECVC7470, UPC Number: 10653160347583.   v. Model Number: ECVC6170, UPC Number: 10653160333395.   w.  Model Number: ECVC3545, UPC Number: 10653160334774.   x. Model Number: ECVC2440B, UPC Number: 10653160358930.   y. Model Number: ECVC7350, UPC Number: 10653160346265.   z. Model Number: ECVC5480, UPC Number: 10653160339458.   aa. Model Number: ECVC3475, UPC Number: 10653160334736.   bb.  Model Number: ECVC2770, UPC Number: 10653160332671.   cc. Model Number: ECVC6370, UPC Number: 10653160333425.    dd. Model Number: ECVC7910, UPC Number: 10653160357254.   ee. Model Number: ECVC7235, UPC Number: 10653160341703; Model Number: ECVC7905, UPC Number: 10653160356912.   ff. Model Number: ECVC2795, UPC Number: 10653160334200.    gg. Model Number: ECVC705, UPC Number: 10653160331889.    hh. Model Number: ECVC7355, UPC Number: 10653160346272.   ii. Model Number: ECVC6640, UPC Number: 10653160333494.   jj. Model Number: DYNJ43851B, UPC Number: 019532720032.   kk. Model Number: DYNJ40629C, UPC Number: 019348999731.   ll. Model Number: DYNJ23455K, UPC Number: 019348956435; Model Number: DYNJ23455L, UPC Number: 019348956435; Model Number: DYNJ23455M, UPC Number: 019348956435; Model Number: DYNJ23455N, UPC Number: 019532723775.   mm. Model Number: DYNJ902507C, UPC Number: 019532713788; Model Number: DYNJ905151B, UPC Number: 019532721996.   nn. Model Number: DYNJ43609O, UPC Number: 019348946871; Model Number: DYNJ43609P, UPC Number: 019348991453; Model Number: DYNJ43609R, UPC Number: 019532722878; Model Number: DYNJ43609S, UPC Number: 019532732298.   oo. Model Number: DYNJ0313233V, UPC Number: 019348956435; Model Number: DYNJ0313233W, UPC Number: 019348956435; Model Number: DYNJ0313233X, UPC Number: 019532725098.   pp. Model Number: DYNJ52000B, UPC Number: 019348938498.   qq. Model Number: DYNJ44320G, UPC Number: 019348996630; Model Number: DYNJ44320I, UPC Number: 019532707035; Model Number: DYNJ44320J, UPC Number: 019532713235.    rr. Model Number: DYNJ47665D, UPC Number: 019348995282; Model Number: DYNJ47665F, UPC Number: 019532735521.   ss. Model Number: DYNJ0037936C, UPC Number: 019348956435; Model Number: DYNJ0037936D, UPC Number: 019532712953.    tt. Model Number: DYNJ42903C, UPC Number: 019532707966; Model Number: DYNJ42903D, UPC Number: 019532717111; Model Number: DYNJ43661C, UPC Number: 019532710435; Model Number: DYNJ44642B, UPC Number: 019532701142; Model Number: DYNJ58111D, UPC Number: 019348993292; Model Number: DYNJ58111F, UPC Number: 019532722351; Model Number: DYNJ69200, UPC Number: 019348990681; Model Number: DYNJ69951, UPC Number: 019532700030.   uu. Model Number: DYNJ0407399P, UPC Number: 019532733686.   vv. Model Number: DYNJ69944, UPC Number: 019348999845.   ww. Model Number: DYNJ23438M, UPC Number: 019348997060; Model Number: DYNJ52121A, UPC Number: 019532726009; Model Number: DYNJ69421, UPC Number: 019348993759; Model Number: DYNJ69792, UPC Number: 019348997928; Model Number: DYNJ82999, UPC Number: 019532722310; Model Number: DYNJ82999A, UPC Number: 019532731027.   xx. Model Number: DYNJ36049A, UPC Number: 019532714720.   yy. Model Number: DYNJ0149444N, UPC Number: 019348996671.    zz. Model Number: DYNJ67320A, UPC Number: 019348993757.   aaa. Model Number: 00-400305R, UPC Number: 019348994428; Model Number: DYNJ49621C, UPC Number: 019532700858; Model Number: DYNJ63060B, UPC Number: 019348991282; Model Number: DYNJ63684G, UPC Number: 019532703722; Model Number: DYNJ68065B, UPC Number: 019532701333.    bbb. Model Number: DYNJ44293F, UPC Number: 019532726518; Model Number: DYNJ45059B, UPC Number: 088994213563; Model Number: DYNJ55252C, UPC Number: 019532726791; Model Number: DYNJ65190D, UPC Number: 019532706664; Model Number: DYNJ65190F, UPC Number: 019532709265; Model Number: DYNJ66476A, UPC Number: 019532705189; Model Number: DYNJ67144A, UPC Number: 019532717902.    ccc. Model Number: DYNJ0290716M, UPC Number: 019532708886; Model Number: DYNJ0854485V, UPC Number: 019532709688.    ddd. Model Number: DYNJ44700J, UPC Number: 019532727741.    eee. Model Number: DYNJ43203G, UPC Number: 019348995291; Model Number: DYNJ64655B, UPC Number: 019348996101; Model Number: DYNJ64655C, UPC Number: 019532717289.    fff. Model Number: DYNJ43261J, UPC Number: 019532728879; Model Number: DYNJ52774, UPC Number: 088994232247; Model Number: DYNJ53095, UPC Number: 088994237177; Model Number: DYNJ55169D, UPC Number: 019348972168; Model Number: DYNJ55169F, UPC Number: 019348984849.    ggg. Model Number: DYNJ62733A, UPC Number: 019348997067.    hhh.  Model Number: ECVC7840A, UPC Number: 10653160355427.    iii. Model Number: STCVC12US, UPC Number: 10653160311829.    jjj. Model Number: ECVC3440, UPC Number: 10653160332770.    kkk. Model Number: ECVC5640A, UPC Number: 10653160339977.    lll. Model Number: ECVC7875, UPC Number: 10653160351535.    mmm. Model Number: ECVC5860, UPC Number: 10653160341543.    nnn. Model Number: ECVC5615, UPC Number: 10653160341512.    ooo. Model Number: ECVC5665, UPC Number: 10653160341505.    ppp. Model Number: ECVC4300, UPC Number: 10653160334873.    qqq. Model Number: ECVC2600, UPC Number: 10653160334279.    rrr. Model Number: ECVC3210, UPC Number: 10653160334071.    sss. Model Number: ECVC7070B, UPC Number: 10653160346166.    ttt. Model Number: DYNJV0177AF, UPC Number: 019348926312.    uuu. Model Number: DYNJ41700A, UPC Number: 088994275695.    vvv. Model Number: DYNJ907014A, UPC Number: 019348947402.    www. Model Number: DYNJ38866D, UPC Number: 019348956435; Model Number: DYNJ38866F, UPC Number: 019348991486; Model Number: DYNJ67174A, UPC Number: 019532704680; Model Number: DYNJ67174B, UPC Number: 019532713108; Model Number: DYNJ82280, UPC Number: 019532718392; Model Number: DYNJ82296, UPC Number: 019532718420.    xxx. Model Number: DYNJ0842644F, UPC Number: 019532728860; Model Number: DYNJ0855138P, UPC Number: 019348956435; Model Number: DYNJ0855138Q, UPC Number: 019532709484; Model Number: DYNJ42996C, UPC Number: 019348998843.    yyy. Model Number: DYNJ45323F, UPC Number: 019532708236.    zzz. Model Number: ECVC2660, UPC Number: 10653160338178.    aaaa. Model Number: DYNJ64050A, UPC Number: 019348994382; Model Number: DYNJ63684G, UPC Number: 019532703722.    bbbb. Model Number: DYNJ66182, UPC Number: 019348932098.    cccc. Model Number: DYNJ33709F, UPC Number: 088994271392.    dddd. Model Number: DYNJ33739G, UPC Number: 088994271393.    eeee. Model Number: DYNJ55680A, UPC Number: 088994263978.    ffff. Model Number: DYNJ68763, UPC Number: 019348983759; Model Number: DYNJ68763A, UPC Number: 019532726478.    gggg. Model Number: DYNJ69864, UPC Number: 019348999048.    hhhh. Model Number: DYNJ40926A, UPC Number: 019532713721; Model Number: DYNJ55455A, UPC Number: 019348938623; Model Number: DYNJ60763, UPC Number: 019348952796; Model Number: DYNJ66166A, UPC Number: 019348939599.    iiii. Model Number: DYNJ67895, UPC Number: 019348945396.    jjjj. Model Number: DYNJ57723B, UPC Number: 019348951627.    kkkk. Model Number: DYNJ80269, UPC Number: 019532701780.    llll. Model Number: DYNJ60329, UPC Number: 088994297098.    mmmm. Model Number: DYNJ51338C, UPC Number: 019348924171; Model Number: DYNJ56547C, UPC Number: 019348987983; Model Number: DYNJ59632D, UPC Number: 019532703407; Model Number: DYNJ63181A, UPC Number: 019532704548; Model Number: DYNJ63181B, UPC Number: 019532712721; Model Number: DYNJ63181C, UPC Number: 019532724200; Model Number: DYNJ66473A, UPC Number: 019348991777; Model Number: DYNJ83089, UPC Number: 019532723083; Model Number: DYNJ83105, UPC Number: 019532723151.    nnnn. Model Number: ECVC6970, UPC Number: 10653160336693.    oooo. Model Number: ECVC360, UPC Number: 10653160332855.    pppp. Model Number: ECVC3285, UPC Number: 10653160336105.    qqqq. Model Number: ECVC2745, UPC Number: 10653160334224.    rrrr. Model Number: ECVC2750, UPC Number: 10653160334217.    ssss. Model Number: ECVC1140A, UPC Number: 10653160331964.    tttt. Model Number: ECVC2300, UPC Number: 10653160334330.    uuuu. Model Number: ECVC2305, UPC Number: 10653160332473.    vvvv. Model Number: ECVC1345A, UPC Number: 10653160334606.    wwww. Model Number: ECVC1725, UPC Number: 10653160334507.    xxxx. Model Number: DYNJ81316, UPC Number: 019532710379.    yyyy. Model Number: ECVC5530A, UPC Number: 10653160345596.    zzzz. Model Number: DYNJ61082C, UPC Number: 019532711141; Model Number: DYNJ61082D, UPC Number: 019532726199.    aaaaa. Model Number: DYNJ0378596I, UPC Number: 10195327188818; Model Number: DYNJ0378596J, UPC Number: 10195327310608.. 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-2297-2023&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-2297-2023&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-2297-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2297-2023 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-2297-2023&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-2297-2023&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-2297-2023/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-2297-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2297-2023",
            "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",
            "Value": "All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ908249A, UPC Number: 019532724050.  b. Model Number: ECVC7410A, UPC Number: 10653160353645.   c. Model Number: ECVC2205A, UPC Number: 10653160357148.   d. Model Number: ECVC8095, UPC Number: 10653160357759.   e. Model Number: ECVC5010A, UPC Number: 10653160335290.   f. Model Number: ECVC6800A, UPC Number: 10653160355694.   g. Model Number: ECVC2555, UPC Number: 10653160336570.   h. Model Number: ECVC4125, UPC Number: 10653160339502.   i. Model Number: ECVC5135B, UPC Number: 10653160353652.   j. Model Number: ECVC7325, UPC Number: 10653160345589.   k. Model Number: ECVC1970B, UPC Number: 10653160357155.   l. Model Number: ECVC4335, UPC Number: 10653160357285.   m. Model Number: ECVC7160, UPC Number: 10653160335306.    n. Model Number: ECVC2560, UPC Number: 10653160334286.     o. Model Number: ECVC3505, UPC Number: 10653160334767.   p. Model Number: ECVC7075, UPC Number: 10653160335122.   q. Model Number: ECVC8055, UPC Number: 10653160355656.   r. Model Number: ECVC8165, UPC Number: 10653160358749.   s. Model Number: ECVC4635A, UPC Number: 10653160352112; Model Number: ECVC7040A, UPC Number: 10653160344414; Model Number: ECVC7430, UPC Number: 10653160346524; Model Number: ECVC7475, UPC Number: 10653160347569; Model Number: ECVC7605, UPC Number: 10653160347743; Model Number: ECVC7675, UPC Number: 10653160348122; Model Number: ECVC8005, UPC Number: 10653160355137; Model Number: ECVC8130, UPC Number: 10653160358343; Model Number: STCVC2055US, UPC Number: 10653160355564.   t. Model Number: ECVC7600, UPC Number: 10653160347736.   u. Model Number: ECVC4640A, UPC Number: 10653160352105; Model Number: ECVC6490A, UPC Number: 10653160344360; Model Number: ECVC6845, UPC Number: 10653160339366; Model Number: ECVC7470, UPC Number: 10653160347583.   v. Model Number: ECVC6170, UPC Number: 10653160333395.   w.  Model Number: ECVC3545, UPC Number: 10653160334774.   x. Model Number: ECVC2440B, UPC Number: 10653160358930.   y. Model Number: ECVC7350, UPC Number: 10653160346265.   z. Model Number: ECVC5480, UPC Number: 10653160339458.   aa. Model Number: ECVC3475, UPC Number: 10653160334736.   bb.  Model Number: ECVC2770, UPC Number: 10653160332671.   cc. Model Number: ECVC6370, UPC Number: 10653160333425.    dd. Model Number: ECVC7910, UPC Number: 10653160357254.   ee. Model Number: ECVC7235, UPC Number: 10653160341703; Model Number: ECVC7905, UPC Number: 10653160356912.   ff. Model Number: ECVC2795, UPC Number: 10653160334200.    gg. Model Number: ECVC705, UPC Number: 10653160331889.    hh. Model Number: ECVC7355, UPC Number: 10653160346272.   ii. Model Number: ECVC6640, UPC Number: 10653160333494.   jj. Model Number: DYNJ43851B, UPC Number: 019532720032.   kk. Model Number: DYNJ40629C, UPC Number: 019348999731.   ll. Model Number: DYNJ23455K, UPC Number: 019348956435; Model Number: DYNJ23455L, UPC Number: 019348956435; Model Number: DYNJ23455M, UPC Number: 019348956435; Model Number: DYNJ23455N, UPC Number: 019532723775.   mm. Model Number: DYNJ902507C, UPC Number: 019532713788; Model Number: DYNJ905151B, UPC Number: 019532721996.   nn. Model Number: DYNJ43609O, UPC Number: 019348946871; Model Number: DYNJ43609P, UPC Number: 019348991453; Model Number: DYNJ43609R, UPC Number: 019532722878; Model Number: DYNJ43609S, UPC Number: 019532732298.   oo. Model Number: DYNJ0313233V, UPC Number: 019348956435; Model Number: DYNJ0313233W, UPC Number: 019348956435; Model Number: DYNJ0313233X, UPC Number: 019532725098.   pp. Model Number: DYNJ52000B, UPC Number: 019348938498.   qq. Model Number: DYNJ44320G, UPC Number: 019348996630; Model Number: DYNJ44320I, UPC Number: 019532707035; Model Number: DYNJ44320J, UPC Number: 019532713235.    rr. Model Number: DYNJ47665D, UPC Number: 019348995282; Model Number: DYNJ47665F, UPC Number: 019532735521.   ss. Model Number: DYNJ0037936C, UPC Number: 019348956435; Model Number: DYNJ0037936D, UPC Number: 019532712953.    tt. Model Number: DYNJ42903C, UPC Number: 019532707966; Model Number: DYNJ42903D, UPC Number: 019532717111; Model Number: DYNJ43661C, UPC Number: 019532710435; Model Number: DYNJ44642B, UPC Number: 019532701142; Model Number: DYNJ58111D, UPC Number: 019348993292; Model Number: DYNJ58111F, UPC Number: 019532722351; Model Number: DYNJ69200, UPC Number: 019348990681; Model Number: DYNJ69951, UPC Number: 019532700030.   uu. Model Number: DYNJ0407399P, UPC Number: 019532733686.   vv. Model Number: DYNJ69944, UPC Number: 019348999845.   ww. Model Number: DYNJ23438M, UPC Number: 019348997060; Model Number: DYNJ52121A, UPC Number: 019532726009; Model Number: DYNJ69421, UPC Number: 019348993759; Model Number: DYNJ69792, UPC Number: 019348997928; Model Number: DYNJ82999, UPC Number: 019532722310; Model Number: DYNJ82999A, UPC Number: 019532731027.   xx. Model Number: DYNJ36049A, UPC Number: 019532714720.   yy. Model Number: DYNJ0149444N, UPC Number: 019348996671.    zz. Model Number: DYNJ67320A, UPC Number: 019348993757.   aaa. Model Number: 00-400305R, UPC Number: 019348994428; Model Number: DYNJ49621C, UPC Number: 019532700858; Model Number: DYNJ63060B, UPC Number: 019348991282; Model Number: DYNJ63684G, UPC Number: 019532703722; Model Number: DYNJ68065B, UPC Number: 019532701333.    bbb. Model Number: DYNJ44293F, UPC Number: 019532726518; Model Number: DYNJ45059B, UPC Number: 088994213563; Model Number: DYNJ55252C, UPC Number: 019532726791; Model Number: DYNJ65190D, UPC Number: 019532706664; Model Number: DYNJ65190F, UPC Number: 019532709265; Model Number: DYNJ66476A, UPC Number: 019532705189; Model Number: DYNJ67144A, UPC Number: 019532717902.    ccc. Model Number: DYNJ0290716M, UPC Number: 019532708886; Model Number: DYNJ0854485V, UPC Number: 019532709688.    ddd. Model Number: DYNJ44700J, UPC Number: 019532727741.    eee. Model Number: DYNJ43203G, UPC Number: 019348995291; Model Number: DYNJ64655B, UPC Number: 019348996101; Model Number: DYNJ64655C, UPC Number: 019532717289.    fff. Model Number: DYNJ43261J, UPC Number: 019532728879; Model Number: DYNJ52774, UPC Number: 088994232247; Model Number: DYNJ53095, UPC Number: 088994237177; Model Number: DYNJ55169D, UPC Number: 019348972168; Model Number: DYNJ55169F, UPC Number: 019348984849.    ggg. Model Number: DYNJ62733A, UPC Number: 019348997067.    hhh.  Model Number: ECVC7840A, UPC Number: 10653160355427.    iii. Model Number: STCVC12US, UPC Number: 10653160311829.    jjj. Model Number: ECVC3440, UPC Number: 10653160332770.    kkk. Model Number: ECVC5640A, UPC Number: 10653160339977.    lll. Model Number: ECVC7875, UPC Number: 10653160351535.    mmm. Model Number: ECVC5860, UPC Number: 10653160341543.    nnn. Model Number: ECVC5615, UPC Number: 10653160341512.    ooo. Model Number: ECVC5665, UPC Number: 10653160341505.    ppp. Model Number: ECVC4300, UPC Number: 10653160334873.    qqq. Model Number: ECVC2600, UPC Number: 10653160334279.    rrr. Model Number: ECVC3210, UPC Number: 10653160334071.    sss. Model Number: ECVC7070B, UPC Number: 10653160346166.    ttt. Model Number: DYNJV0177AF, UPC Number: 019348926312.    uuu. Model Number: DYNJ41700A, UPC Number: 088994275695.    vvv. Model Number: DYNJ907014A, UPC Number: 019348947402.    www. Model Number: DYNJ38866D, UPC Number: 019348956435; Model Number: DYNJ38866F, UPC Number: 019348991486; Model Number: DYNJ67174A, UPC Number: 019532704680; Model Number: DYNJ67174B, UPC Number: 019532713108; Model Number: DYNJ82280, UPC Number: 019532718392; Model Number: DYNJ82296, UPC Number: 019532718420.    xxx. Model Number: DYNJ0842644F, UPC Number: 019532728860; Model Number: DYNJ0855138P, UPC Number: 019348956435; Model Number: DYNJ0855138Q, UPC Number: 019532709484; Model Number: DYNJ42996C, UPC Number: 019348998843.    yyy. Model Number: DYNJ45323F, UPC Number: 019532708236.    zzz. Model Number: ECVC2660, UPC Number: 10653160338178.    aaaa. Model Number: DYNJ64050A, UPC Number: 019348994382; Model Number: DYNJ63684G, UPC Number: 019532703722.    bbbb. Model Number: DYNJ66182, UPC Number: 019348932098.    cccc. Model Number: DYNJ33709F, UPC Number: 088994271392.    dddd. Model Number: DYNJ33739G, UPC Number: 088994271393.    eeee. Model Number: DYNJ55680A, UPC Number: 088994263978.    ffff. Model Number: DYNJ68763, UPC Number: 019348983759; Model Number: DYNJ68763A, UPC Number: 019532726478.    gggg. Model Number: DYNJ69864, UPC Number: 019348999048.    hhhh. Model Number: DYNJ40926A, UPC Number: 019532713721; Model Number: DYNJ55455A, UPC Number: 019348938623; Model Number: DYNJ60763, UPC Number: 019348952796; Model Number: DYNJ66166A, UPC Number: 019348939599.    iiii. Model Number: DYNJ67895, UPC Number: 019348945396.    jjjj. Model Number: DYNJ57723B, UPC Number: 019348951627.    kkkk. Model Number: DYNJ80269, UPC Number: 019532701780.    llll. Model Number: DYNJ60329, UPC Number: 088994297098.    mmmm. Model Number: DYNJ51338C, UPC Number: 019348924171; Model Number: DYNJ56547C, UPC Number: 019348987983; Model Number: DYNJ59632D, UPC Number: 019532703407; Model Number: DYNJ63181A, UPC Number: 019532704548; Model Number: DYNJ63181B, UPC Number: 019532712721; Model Number: DYNJ63181C, UPC Number: 019532724200; Model Number: DYNJ66473A, UPC Number: 019348991777; Model Number: DYNJ83089, UPC Number: 019532723083; Model Number: DYNJ83105, UPC Number: 019532723151.    nnnn. Model Number: ECVC6970, UPC Number: 10653160336693.    oooo. Model Number: ECVC360, UPC Number: 10653160332855.    pppp. Model Number: ECVC3285, UPC Number: 10653160336105.    qqqq. Model Number: ECVC2745, UPC Number: 10653160334224.    rrrr. Model Number: ECVC2750, UPC Number: 10653160334217.    ssss. Model Number: ECVC1140A, UPC Number: 10653160331964.    tttt. Model Number: ECVC2300, UPC Number: 10653160334330.    uuuu. Model Number: ECVC2305, UPC Number: 10653160332473.    vvvv. Model Number: ECVC1345A, UPC Number: 10653160334606.    wwww. Model Number: ECVC1725, UPC Number: 10653160334507.    xxxx. Model Number: DYNJ81316, UPC Number: 019532710379.    yyyy. Model Number: ECVC5530A, UPC Number: 10653160345596.    zzzz. Model Number: DYNJ61082C, UPC Number: 019532711141; Model Number: DYNJ61082D, UPC Number: 019532726199.    aaaaa. Model Number: DYNJ0378596I, UPC Number: 10195327188818; Model Number: DYNJ0378596J, UPC Number: 10195327310608.",
            "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"
          }
        }
      ]
    }
  ]
}