{
  "@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-2298-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200;    q. CVC BUNDLE KIT OR, Model Number: ECVC2205;   r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A;   s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120;   u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150;   v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B;    w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105;   x. CVC HEART PACK, Model Number: ECVC7360;   y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A;   z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860;   aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895;   bb.  CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315;   cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310;    dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555;    ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286;    ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A;    gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A;    hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;    ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525;    jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850;    kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A;    ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300;    mm. CVC KIT WITH CATHETER, Model Number: ECVC885;    nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105;    oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B;    pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235;    qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B;    rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B;    ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400;    tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465;    uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070;    vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940;    ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J;    xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L;    yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297;    zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D;    aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;    bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A;    ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531;    ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336;    eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G;     fff. DIALYSIS TRAY, Model Number: DYNJ43060B;    ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A;    hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985;    iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940;    jjj. ECMO PACK 2, Model Number: DYNJ82079;    kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691;    lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B;    mmm. EPS PACK, Model Number: DYNJ46545C;    nnn. EV LAB PACK, Mo",
  "description": "FDA recall Z-2298-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200;    q. CVC BUNDLE KIT OR, Model Number: ECVC2205;   r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A;   s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120;   u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150;   v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B;    w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105;   x. CVC HEART PACK, Model Number: ECVC7360;   y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A;   z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860;   aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895;   bb.  CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315;   cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310;    dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555;    ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286;    ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A;    gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A;    hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;    ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525;    jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850;    kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A;    ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300;    mm. CVC KIT WITH CATHETER, Model Number: ECVC885;    nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105;    oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B;    pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235;    qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B;    rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B;    ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400;    tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465;    uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070;    vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940;    ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J;    xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L;    yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297;    zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D;    aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;    bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A;    ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531;    ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336;    eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G;     fff. DIALYSIS TRAY, Model Number: DYNJ43060B;    ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A;    hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985;    iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940;    jjj. ECMO PACK 2, Model Number: DYNJ82079;    kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691;    lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B;    mmm. EPS PACK, Model Number: DYNJ46545C;    nnn. EV LAB PACK, Mo (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-2298-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200;    q. CVC BUNDLE KIT OR, Model Number: ECVC2205;   r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A;   s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120;   u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150;   v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B;    w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105;   x. CVC HEART PACK, Model Number: ECVC7360;   y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A;   z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860;   aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895;   bb.  CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315;   cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310;    dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555;    ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286;    ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A;    gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A;    hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;    ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525;    jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850;    kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A;    ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300;    mm. CVC KIT WITH CATHETER, Model Number: ECVC885;    nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105;    oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B;    pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235;    qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B;    rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B;    ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400;    tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465;    uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070;    vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940;    ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J;    xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L;    yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297;    zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D;    aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;    bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A;    ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531;    ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336;    eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G;     fff. DIALYSIS TRAY, Model Number: DYNJ43060B;    ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A;    hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985;    iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940;    jjj. ECMO PACK 2, Model Number: DYNJ82079;    kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691;    lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B;    mmm. EPS PACK, Model Number: DYNJ46545C;    nnn. EV LAB PACK, Mo",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2298-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2298-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200;    q. CVC BUNDLE KIT OR, Model Number: ECVC2205;   r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A;   s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120;   u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150;   v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B;    w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105;   x. CVC HEART PACK, Model Number: ECVC7360;   y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A;   z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860;   aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895;   bb.  CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315;   cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310;    dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555;    ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286;    ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A;    gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A;    hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;    ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525;    jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850;    kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A;    ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300;    mm. CVC KIT WITH CATHETER, Model Number: ECVC885;    nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105;    oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B;    pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235;    qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B;    rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B;    ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400;    tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465;    uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070;    vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940;    ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J;    xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L;    yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297;    zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D;    aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;    bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A;    ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531;    ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336;    eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G;     fff. DIALYSIS TRAY, Model Number: DYNJ43060B;    ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A;    hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985;    iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940;    jjj. ECMO PACK 2, Model Number: DYNJ82079;    kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691;    lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B;    mmm. EPS PACK, Model Number: DYNJ46545C;    nnn. EV LAB PACK, Mo",
      "text": "The FDA logged enforcement record Z-2298-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200;    q. CVC BUNDLE KIT OR, Model Number: ECVC2205;   r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A;   s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120;   u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150;   v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B;    w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105;   x. CVC HEART PACK, Model Number: ECVC7360;   y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A;   z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860;   aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895;   bb.  CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315;   cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310;    dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555;    ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286;    ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A;    gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A;    hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;    ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525;    jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850;    kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A;    ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300;    mm. CVC KIT WITH CATHETER, Model Number: ECVC885;    nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105;    oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B;    pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235;    qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B;    rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B;    ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400;    tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465;    uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070;    vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940;    ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J;    xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L;    yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297;    zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D;    aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;    bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A;    ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531;    ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336;    eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G;     fff. DIALYSIS TRAY, Model Number: DYNJ43060B;    ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A;    hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985;    iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940;    jjj. ECMO PACK 2, Model Number: DYNJ82079;    kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691;    lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B;    mmm. EPS PACK, Model Number: DYNJ46545C;    nnn. EV LAB PACK, Mo — 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: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200.  b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198.  c. Model Number: DYNJ41649G, UPC Number: 019532727729.  d. Model Number: ECVC2595, UPC Number: 10653160332596.  e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205.  f. Model Number: ECVC2225, UPC Number: 10653160334385.   g. Model Number: ECVC7265A, UPC Number: 10653160345145.  h. Model Number: ECVC3235, UPC Number: 10653160336112.  i. Model Number: ECVC2335, UPC Number: 10653160332497.  j. Model Number: ECVC5120B, UPC Number: 10653160333180.  k. Model Number: ECVC5095B, UPC Number: 10653160333173.  l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085.  m. Model Number: ECVC2240A, UPC Number: 10653160334361.   n. Model Number: ECVC2001, UPC Number: 10653160334415.     o. Model Number: ECVC7205A, UPC Number: 10653160342007.  p. Model Number: ECVC7200, UPC Number: 10653160341680.  q. Model Number: ECVC2205, UPC Number: 10653160332435.  r. Model Number: ECVC1970A, UPC Number: 10653160346159.  s. Model Number: ECVC5540A, UPC Number: 10653160335009.   t. Model Number: ECVC6120, UPC Number: 10653160336532.  u. Model Number: ECVC6150, UPC Number: 10653160335054.   v. Model Number: ECVC5095B, UPC Number: 10653160333173.   w.  Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858.  x. Model Number: ECVC7360, UPC Number: 10653160346289.  y. Model Number: ECVC3755A, UPC Number: 10653160334804.  z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191.   aa. Model Number: ECVC2895, UPC Number: 10653160332725.   bb.  Model Number: ECVC5315, UPC Number: 10653160339465.   cc. Model Number: ECVC5310, UPC Number: 10653160336211.    dd. Model Number: ECVC1555, UPC Number: 10653160331759.   ee. Model Number: ECVC3286, UPC Number: 10653160358398.   ff. Model Number: ECVC3285A, UPC Number: 10653160358572.   gg. Model Number: ECVC5560A, UPC Number: 10653160336501.   hh. Model Number: ECVC6355, UPC Number: 10653160336396.   ii. Model Number: ECVC1525, UPC Number: 10653160334545.   jj. Model Number: ECVC6850, UPC Number: 10653160338819.   kk. Model Number: ECVC5525A, UPC Number: 10653160338130.   ll. Model Number: ECVC1300, UPC Number: 10653160331780.   mm. Model Number: ECVC885, UPC Number: 10653160333562.   nn. Model Number: ECVC105, UPC Number: 10653160331773.   oo. Model Number: ECVC5590B, UPC Number: 10653160357728.   pp. Model Number: ECVC2235, UPC Number: 10653160334378.   qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704.   rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797.   ss. Model Number: ECVC400, UPC Number: 10653160331827.   tt. Model Number: ECVC465, UPC Number: 10653160333074.   uu. Model Number: ECVC6070, UPC Number: 10653160335863.   vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709.   ww. Model Number: DYNJ44320J, UPC Number: 019532713235.   xx. Model Number: DYNJ0429185L, UPC Number: 019532704897.   yy. Model Number: DYNJ80297, UPC Number: 019532702177.   zz. Model Number: DYNJ61118D, UPC Number: 019532710821.   aaa. Model Number: DYNJ41649G, UPC Number: 019532727729.   bbb. Model Number: DYNJ58510A, UPC Number: 019348981743.   ccc. Model Number: DYNJ42531, UPC Number: 088438992673.    ddd. Model Number: PAIN1336, UPC Number: 019348951153.     eee. Model Number: DYNJ0198765G, UPC Number: 088994205398.   fff. Model Number: DYNJ43060B, UPC Number: 088994276585.   ggg. Model Number: DYNJ67149A, UPC Number: 019532717903.   hhh.  Model Number: ECVC4985, UPC Number: 10653160335269.   iii. Model Number: ECVC2940, UPC Number: 10653160335351.    jjj. Model Number: DYNJ82079, UPC Number: 019532716736.    kkk. Model Number: DYNJ69691, UPC Number: 019348997011.   lll. Model Number: DYNJ47645B, UPC Number: 019348995283.    mmm. Model Number: DYNJ46545C, UPC Number: 019532725042.   nnn. Model Number: DYNJ53481D, UPC Number: 019348981257.    ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949.   ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690.   qqq. Model Number: DYNJ909393, UPC Number: 019532733558.   rrr. Model Number: DYNJ66515A, UPC Number: 019348940616.     sss. Model Number: ECVC2320, UPC Number: 10653160332480.   ttt. Model Number: ECVC2720, UPC Number: 10653160332657.   uuu. Model Number: DYNJ57760C, UPC Number: 019532707939.    vvv. Model Number: DYNJ65174D, UPC Number: 019348996215.   www. Model Number: DYNJ69298, UPC Number: 019348992541.   xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773.   yyy. Model Number: DYNJ81213, UPC Number: 019532709427.     zzz. Model Number: SYNJ10303C, UPC Number: 019532711889.    aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504.   bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351.   cccc. Model Number: DYNJ40215B, UPC Number: 088827791226.   dddd. Model Number: ECVC3705, UPC Number: 10653160332893.    eeee. Model Number: ECVC1915, UPC Number: 10653160334446.   ffff. Model Number: ECVC1915, UPC Number: 10653160334446.    gggg. Model Number: STCVC09US, UPC Number: 10653160342939.   hhhh. Model Number: STCVC10US, UPC Number: 10653160343097.   iiii. Model Number: ECVC6265, UPC Number: 10653160342922.     jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792.    kkkk. Model Number: DYNJ64976, UPC Number: 019348923712.   llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091.    mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735.    nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129.    oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129.    pppp. Model Number: DYNJ36738G, UPC Number: 019532705416.    qqqq. Model Number: ECVC6555, UPC Number: 10653160336341.    rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466.   ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767.     tttt. Model Number: DYNJ61373A, UPC Number: 019532701469.    uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113.     vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932.    wwww. Model Number: DYNJ69898, UPC Number: 019348999389.    xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013.    yyyy. Model Number: ECVC2650, UPC Number: 10653160334248.    zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.. 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-2298-2023&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-2298-2023&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-2298-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2298-2023 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-2298-2023&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-2298-2023&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-2298-2023/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-2298-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2298-2023",
            "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: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200.  b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198.  c. Model Number: DYNJ41649G, UPC Number: 019532727729.  d. Model Number: ECVC2595, UPC Number: 10653160332596.  e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205.  f. Model Number: ECVC2225, UPC Number: 10653160334385.   g. Model Number: ECVC7265A, UPC Number: 10653160345145.  h. Model Number: ECVC3235, UPC Number: 10653160336112.  i. Model Number: ECVC2335, UPC Number: 10653160332497.  j. Model Number: ECVC5120B, UPC Number: 10653160333180.  k. Model Number: ECVC5095B, UPC Number: 10653160333173.  l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085.  m. Model Number: ECVC2240A, UPC Number: 10653160334361.   n. Model Number: ECVC2001, UPC Number: 10653160334415.     o. Model Number: ECVC7205A, UPC Number: 10653160342007.  p. Model Number: ECVC7200, UPC Number: 10653160341680.  q. Model Number: ECVC2205, UPC Number: 10653160332435.  r. Model Number: ECVC1970A, UPC Number: 10653160346159.  s. Model Number: ECVC5540A, UPC Number: 10653160335009.   t. Model Number: ECVC6120, UPC Number: 10653160336532.  u. Model Number: ECVC6150, UPC Number: 10653160335054.   v. Model Number: ECVC5095B, UPC Number: 10653160333173.   w.  Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858.  x. Model Number: ECVC7360, UPC Number: 10653160346289.  y. Model Number: ECVC3755A, UPC Number: 10653160334804.  z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191.   aa. Model Number: ECVC2895, UPC Number: 10653160332725.   bb.  Model Number: ECVC5315, UPC Number: 10653160339465.   cc. Model Number: ECVC5310, UPC Number: 10653160336211.    dd. Model Number: ECVC1555, UPC Number: 10653160331759.   ee. Model Number: ECVC3286, UPC Number: 10653160358398.   ff. Model Number: ECVC3285A, UPC Number: 10653160358572.   gg. Model Number: ECVC5560A, UPC Number: 10653160336501.   hh. Model Number: ECVC6355, UPC Number: 10653160336396.   ii. Model Number: ECVC1525, UPC Number: 10653160334545.   jj. Model Number: ECVC6850, UPC Number: 10653160338819.   kk. Model Number: ECVC5525A, UPC Number: 10653160338130.   ll. Model Number: ECVC1300, UPC Number: 10653160331780.   mm. Model Number: ECVC885, UPC Number: 10653160333562.   nn. Model Number: ECVC105, UPC Number: 10653160331773.   oo. Model Number: ECVC5590B, UPC Number: 10653160357728.   pp. Model Number: ECVC2235, UPC Number: 10653160334378.   qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704.   rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797.   ss. Model Number: ECVC400, UPC Number: 10653160331827.   tt. Model Number: ECVC465, UPC Number: 10653160333074.   uu. Model Number: ECVC6070, UPC Number: 10653160335863.   vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709.   ww. Model Number: DYNJ44320J, UPC Number: 019532713235.   xx. Model Number: DYNJ0429185L, UPC Number: 019532704897.   yy. Model Number: DYNJ80297, UPC Number: 019532702177.   zz. Model Number: DYNJ61118D, UPC Number: 019532710821.   aaa. Model Number: DYNJ41649G, UPC Number: 019532727729.   bbb. Model Number: DYNJ58510A, UPC Number: 019348981743.   ccc. Model Number: DYNJ42531, UPC Number: 088438992673.    ddd. Model Number: PAIN1336, UPC Number: 019348951153.     eee. Model Number: DYNJ0198765G, UPC Number: 088994205398.   fff. Model Number: DYNJ43060B, UPC Number: 088994276585.   ggg. Model Number: DYNJ67149A, UPC Number: 019532717903.   hhh.  Model Number: ECVC4985, UPC Number: 10653160335269.   iii. Model Number: ECVC2940, UPC Number: 10653160335351.    jjj. Model Number: DYNJ82079, UPC Number: 019532716736.    kkk. Model Number: DYNJ69691, UPC Number: 019348997011.   lll. Model Number: DYNJ47645B, UPC Number: 019348995283.    mmm. Model Number: DYNJ46545C, UPC Number: 019532725042.   nnn. Model Number: DYNJ53481D, UPC Number: 019348981257.    ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949.   ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690.   qqq. Model Number: DYNJ909393, UPC Number: 019532733558.   rrr. Model Number: DYNJ66515A, UPC Number: 019348940616.     sss. Model Number: ECVC2320, UPC Number: 10653160332480.   ttt. Model Number: ECVC2720, UPC Number: 10653160332657.   uuu. Model Number: DYNJ57760C, UPC Number: 019532707939.    vvv. Model Number: DYNJ65174D, UPC Number: 019348996215.   www. Model Number: DYNJ69298, UPC Number: 019348992541.   xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773.   yyy. Model Number: DYNJ81213, UPC Number: 019532709427.     zzz. Model Number: SYNJ10303C, UPC Number: 019532711889.    aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504.   bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351.   cccc. Model Number: DYNJ40215B, UPC Number: 088827791226.   dddd. Model Number: ECVC3705, UPC Number: 10653160332893.    eeee. Model Number: ECVC1915, UPC Number: 10653160334446.   ffff. Model Number: ECVC1915, UPC Number: 10653160334446.    gggg. Model Number: STCVC09US, UPC Number: 10653160342939.   hhhh. Model Number: STCVC10US, UPC Number: 10653160343097.   iiii. Model Number: ECVC6265, UPC Number: 10653160342922.     jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792.    kkkk. Model Number: DYNJ64976, UPC Number: 019348923712.   llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091.    mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735.    nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129.    oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129.    pppp. Model Number: DYNJ36738G, UPC Number: 019532705416.    qqqq. Model Number: ECVC6555, UPC Number: 10653160336341.    rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466.   ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767.     tttt. Model Number: DYNJ61373A, UPC Number: 019532701469.    uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113.     vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932.    wwww. Model Number: DYNJ69898, UPC Number: 019348999389.    xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013.    yyyy. Model Number: ECVC2650, UPC Number: 10653160334248.    zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.",
            "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"
          }
        }
      ]
    }
  ]
}