{
  "@context": {
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    "@vocab": "https://schema.org/",
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      "@container": "@list"
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    "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"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2302-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;     o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295;     p. PACER SET UP PACK, Model Number: DYNJ63069A;     q. PACK AV FISTULA, Model Number: DYNJ60115B;     r. PACK MINOR VASCULAR, Model Number: NG340C;     s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D;     t. PEDI EP PACK, Model Number: DYNJ54750G;     u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G;     v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I;     w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A;     x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I;     y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C;     z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566;     aa. PERMA CATH PACK, Model Number: DYNJ62007B;     bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010;     cc. PK  OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A;     dd. PK, OPEN HEART, Model Number: DYNJ61645A;     ee. PK, VASCULAR, Model Number: DYNJ54305;     ff. PORT PACK, Model Number: DYNJ68990A;     gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A;     hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492;     ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618;     jj. PRX AV FISTULA PACK, Model Number: DYNJ66184;     kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C;     ll. PUMP PACK, Model Number: DYNJ64601B;     mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B;     nn. PV CAROTID PACK, Model Number: DYNJ63341D;     oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L;     pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K;     qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A;     rr. RFD-CAROTID, Model Number: DYNJ54287B;     ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A;     tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B;     uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B;     vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379D;     xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C;     yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L;     zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B;     aaa. SCA VEIN PACK, Model Number: DYNJ63817;     bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F;     ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521;     ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418;     eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314;     fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I;     ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C;     hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918;     iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563;     jjj. STROKE KIT, Model Number: DYNJ80506;     kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A;     lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B;     mmm. SVMMC  CAROTID PACK, Model Number: DYNJ43861F;     nnn. SVMMC AV",
  "description": "FDA recall Z-2302-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;     o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295;     p. PACER SET UP PACK, Model Number: DYNJ63069A;     q. PACK AV FISTULA, Model Number: DYNJ60115B;     r. PACK MINOR VASCULAR, Model Number: NG340C;     s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D;     t. PEDI EP PACK, Model Number: DYNJ54750G;     u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G;     v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I;     w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A;     x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I;     y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C;     z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566;     aa. PERMA CATH PACK, Model Number: DYNJ62007B;     bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010;     cc. PK  OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A;     dd. PK, OPEN HEART, Model Number: DYNJ61645A;     ee. PK, VASCULAR, Model Number: DYNJ54305;     ff. PORT PACK, Model Number: DYNJ68990A;     gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A;     hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492;     ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618;     jj. PRX AV FISTULA PACK, Model Number: DYNJ66184;     kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C;     ll. PUMP PACK, Model Number: DYNJ64601B;     mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B;     nn. PV CAROTID PACK, Model Number: DYNJ63341D;     oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L;     pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K;     qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A;     rr. RFD-CAROTID, Model Number: DYNJ54287B;     ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A;     tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B;     uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B;     vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379D;     xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C;     yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L;     zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B;     aaa. SCA VEIN PACK, Model Number: DYNJ63817;     bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F;     ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521;     ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418;     eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314;     fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I;     ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C;     hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918;     iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563;     jjj. STROKE KIT, Model Number: DYNJ80506;     kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A;     lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B;     mmm. SVMMC  CAROTID PACK, Model Number: DYNJ43861F;     nnn. SVMMC AV (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-2302-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;     o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295;     p. PACER SET UP PACK, Model Number: DYNJ63069A;     q. PACK AV FISTULA, Model Number: DYNJ60115B;     r. PACK MINOR VASCULAR, Model Number: NG340C;     s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D;     t. PEDI EP PACK, Model Number: DYNJ54750G;     u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G;     v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I;     w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A;     x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I;     y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C;     z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566;     aa. PERMA CATH PACK, Model Number: DYNJ62007B;     bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010;     cc. PK  OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A;     dd. PK, OPEN HEART, Model Number: DYNJ61645A;     ee. PK, VASCULAR, Model Number: DYNJ54305;     ff. PORT PACK, Model Number: DYNJ68990A;     gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A;     hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492;     ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618;     jj. PRX AV FISTULA PACK, Model Number: DYNJ66184;     kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C;     ll. PUMP PACK, Model Number: DYNJ64601B;     mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B;     nn. PV CAROTID PACK, Model Number: DYNJ63341D;     oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L;     pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K;     qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A;     rr. RFD-CAROTID, Model Number: DYNJ54287B;     ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A;     tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B;     uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B;     vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379D;     xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C;     yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L;     zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B;     aaa. SCA VEIN PACK, Model Number: DYNJ63817;     bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F;     ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521;     ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418;     eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314;     fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I;     ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C;     hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918;     iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563;     jjj. STROKE KIT, Model Number: DYNJ80506;     kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A;     lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B;     mmm. SVMMC  CAROTID PACK, Model Number: DYNJ43861F;     nnn. SVMMC AV",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2302-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2302-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;     o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295;     p. PACER SET UP PACK, Model Number: DYNJ63069A;     q. PACK AV FISTULA, Model Number: DYNJ60115B;     r. PACK MINOR VASCULAR, Model Number: NG340C;     s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D;     t. PEDI EP PACK, Model Number: DYNJ54750G;     u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G;     v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I;     w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A;     x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I;     y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C;     z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566;     aa. PERMA CATH PACK, Model Number: DYNJ62007B;     bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010;     cc. PK  OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A;     dd. PK, OPEN HEART, Model Number: DYNJ61645A;     ee. PK, VASCULAR, Model Number: DYNJ54305;     ff. PORT PACK, Model Number: DYNJ68990A;     gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A;     hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492;     ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618;     jj. PRX AV FISTULA PACK, Model Number: DYNJ66184;     kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C;     ll. PUMP PACK, Model Number: DYNJ64601B;     mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B;     nn. PV CAROTID PACK, Model Number: DYNJ63341D;     oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L;     pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K;     qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A;     rr. RFD-CAROTID, Model Number: DYNJ54287B;     ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A;     tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B;     uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B;     vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379D;     xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C;     yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L;     zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B;     aaa. SCA VEIN PACK, Model Number: DYNJ63817;     bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F;     ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521;     ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418;     eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314;     fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I;     ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C;     hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918;     iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563;     jjj. STROKE KIT, Model Number: DYNJ80506;     kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A;     lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B;     mmm. SVMMC  CAROTID PACK, Model Number: DYNJ43861F;     nnn. SVMMC AV",
      "text": "The FDA logged enforcement record Z-2302-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;     o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295;     p. PACER SET UP PACK, Model Number: DYNJ63069A;     q. PACK AV FISTULA, Model Number: DYNJ60115B;     r. PACK MINOR VASCULAR, Model Number: NG340C;     s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D;     t. PEDI EP PACK, Model Number: DYNJ54750G;     u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G;     v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I;     w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A;     x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I;     y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C;     z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566;     aa. PERMA CATH PACK, Model Number: DYNJ62007B;     bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010;     cc. PK  OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A;     dd. PK, OPEN HEART, Model Number: DYNJ61645A;     ee. PK, VASCULAR, Model Number: DYNJ54305;     ff. PORT PACK, Model Number: DYNJ68990A;     gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A;     hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492;     ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618;     jj. PRX AV FISTULA PACK, Model Number: DYNJ66184;     kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C;     ll. PUMP PACK, Model Number: DYNJ64601B;     mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B;     nn. PV CAROTID PACK, Model Number: DYNJ63341D;     oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L;     pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K;     qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A;     rr. RFD-CAROTID, Model Number: DYNJ54287B;     ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A;     tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B;     uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B;     vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379D;     xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C;     yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L;     zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B;     aaa. SCA VEIN PACK, Model Number: DYNJ63817;     bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F;     ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521;     ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418;     eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314;     fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I;     ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C;     hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918;     iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563;     jjj. STROKE KIT, Model Number: DYNJ80506;     kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A;     lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B;     mmm. SVMMC  CAROTID PACK, Model Number: DYNJ43861F;     nnn. SVMMC AV — 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: CDS840451L, UPC Number: 019532715163.   b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257.   c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365;  Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492.   d. Model Number: DYNJ53984G, UPC Number: 019532728288.   e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288.   f. Model Number: DYNJ0371669N, UPC Number: 019348923039.   g. Model Number: DYNJ22232W, UPC Number: 019532732560.   h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355.   i. Model Number: DYNJ901821A, UPC Number: 019532731932.   j. Model Number: DYNJ63153B, UPC Number: 019348984168.   k. Model Number: DYNJ63099F, UPC Number: 019532715003.   l. Model Number: DYNJ907858A, UPC Number: 019532713135.   m. Model Number: DYNJ62451, UPC Number: 019348965833.   n. Model Number: DYNJ906019C, UPC Number: 019348941128.   o. Model Number: DYNJ81295, UPC Number: 019532710670.   p. Model Number: DYNJ63069A, UPC Number: 019348942361.   q. Model Number: DYNJ60115B, UPC Number: 019532711880.   r. Model Number: NG340C, UPC Number: 019532730520.   s. Model Number: DYNJ905692D, UPC Number: 019532720229.   t. Model Number: DYNJ54750G, UPC Number: 019532702135.   u. Model Number: DYNJ35578G, UPC Number: 019348980860.   v. Model Number: CDS840487I, UPC Number: 019348944534.   w. Model Number: PAIN1423A, UPC Number: 019348920182.   x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F, UPC Number: 019348994461; Model Number: DYNJ901068I, UPC Number: 019532723251.   y. Model Number: SYNJ910022A, UPC Number: 019348937421; Model Number: SYNJ910022B, UPC Number: 019532700726; Model Number: SYNJ910022C, UPC Number: 019532735820.   z. Model Number: DYNJ82566, UPC Number: 019532719802.   aa. Model Number: DYNJ62007B, UPC Number: 019532716196.   bb. Model Number: PICCNC0010, UPC Number: 019532723117.   cc. Model Number: DYNJ45074C, UPC Number: 019348922267; Model Number: DYNJ61645A, UPC Number: 019348978134.   dd. Model Number: DYNJ61645A, UPC Number: 019348978134.   ee. Model Number: DYNJ54305, UPC Number: 088994247639.   ff. Model Number: DYNJ68990A, UPC Number: 019348998136.   gg. Model Number: DYNJ65775A, UPC Number: 019532714022.   hh. Model Number: DYNJ68492, UPC Number: 019348982724.   ii. Model Number: DYNJ43922, UPC Number: 088827707466; Model Number: DYNJ68968A, UPC Number: 019532720684; Model Number: DYNJ81618, UPC Number: 019532712460.   jj. Model Number: DYNJ66184, UPC Number: 019348932118.   kk. Model Number: DYNJ907554A, UPC Number: 019532702463; Model Number: DYNJ907554C, UPC Number: 019532718383.   ll. Model Number: DYNJ64601B, UPC Number: 019532728473.   mm. Model Number: DYNJ62197A, UPC Number: 019348999409; Model Number: DYNJ62197B, UPC Number: 019532716724.   nn. Model Number: DYNJ63341D, UPC Number: 019532727362.   oo. Model Number: DYNJ46549K, UPC Number: 019532700829; Model Number: DYNJ46549L, UPC Number: 019532729066.   pp. Model Number: DYNJ47660K, UPC Number: 019348987573.   qq. Model Number: DYNJ61894A, UPC Number: 019348973096.   rr. Model Number: DYNJ54287B, UPC Number: 019532716711.   ss. Model Number: DYNJ54265A, UPC Number: 019532715233.   tt. Model Number: DYNJ54285B, UPC Number: 019532714203.   uu. Model Number: DYNJ54286B, UPC Number: 019532714578.   vv. Model Number: DYNJ0565558U, UPC Number: 019348982703.   ww. Model Number: DYNJ40379D, UPC Number: 019348925761.   xx. Model Number: DYNJ55757C, UPC Number: 019532711653.   yy. Model Number: DYNJ33544J, UPC Number: 019348956435; Model Number: DYNJ33544K, UPC Number: 019348956435; Model Number: DYNJ33544L, UPC Number: 019532727931.   zz. Model Number: DYNJ908074B, UPC Number: 019532717268.   aaa. Model Number: DYNJ63817, UPC Number: 019348976395.   bbb. Model Number: DYNJ906102D, UPC Number: 019348982234; Model Number: DYNJ906102F, UPC Number: 019532702826.   ccc. Model Number: DYNJ83521, UPC Number: 019532727464.   ddd. Model Number: DYNJ65418, UPC Number: 019348927371.   eee. Model Number: DYNJ82314, UPC Number: 019532718421.   fff. Model Number: DYNJ49833I, UPC Number: 019348988536.   ggg. Model Number: DYNJ20031C, UPC Number: 088438965007.   hhh.  Model Number: DYNJ80918, UPC Number: 019532708492.   iii. Model Number: DYNJ908563, UPC Number: 019532708642.   jjj. Model Number: DYNJ80506, UPC Number: 019532704917.   kkk. Model Number: DYNJ69009, UPC Number: 019348987684; Model Number: DYNJ69009A, UPC Number: 019532707556.   lll. Model Number: DYNJ54014B, UPC Number: 088994276032.   mmm. Model Number: DYNJ43861F, UPC Number: 019348998164.   nnn. Model Number: DYNJ48153F, UPC Number: 019348998969.   ooo. Model Number: DYNJ43777J, UPC Number: 019348999018.   ppp. Model Number: DYNJ57539B, UPC Number: 019348930066; Model Number: DYNJ907561, UPC Number: 019348982123; Model Number: DYNJ907561A, UPC Number: 019532702884; Model Number: DYNJ908646, UPC Number: 019532712395;  Model Number: DYNJ908646A, UPC Number: 019532731496.   qqq. Model Number: DYNJ904401C, UPC Number: 019348934891; Model Number: DYNJ905859, UPC Number: 019348954552.   rrr. Model Number: DYNJ52766A, UPC Number: 019348929236; Model Number: DYNJ62915B, UPC Number: 019348936535; Model Number: DYNJ63340A, UPC Number: 019532727358; Model Number: DYNJ66769, UPC Number: 019348938052; Model Number: DYNJ68933, UPC Number: 019348986037; Model Number: DYNJ81095, UPC Number: 019532708412; Model Number: DYNJ82863A, UPC Number: 019532724504.   sss. Model Number: DYNJ66152A, UPC Number: 019348982021; Model Number: DYNJ66152B, UPC Number: 019532709042.   ttt. Model Number: DYNJ906391D, UPC Number: 019532702147.   uuu. Model Number: DYNJ903919J, UPC Number: 019532704590; Model Number: DYNJ903919K, UPC Number: 019532721878; Model Number: DYNJ903919L, UPC Number: 019532726705.   vvv. Model Number: DYNJ64449, UPC Number: 019348920157.   www. Model Number: TVS4000L, UPC Number: 019532722354.   xxx. Model Number: DYNJ55427B, UPC Number: 019348978611; Model Number: DYNJ55427C, UPC Number: 019532712656; Model Number: DYNJ55427D, UPC Number: 019532727261.   yyy. Model Number: DYNJ907201, UPC Number: 019348935833; Model Number: DYNJ907201B, UPC Number: 019348994665.   zzz. Model Number: DYNJ69622, UPC Number: 019348995958.   aaaa. Model Number: DYNJ69302, UPC Number: 019348992627.   bbbb. Model Number: DYNJ81705, UPC Number: 019532713557.   cccc. Model Number: DYNJ906882A, UPC Number: 019348939123.   dddd. Model Number: DYNJ58915, UPC Number: 088994290385; Model Number: DYNJ65842, UPC Number: 019348929631.   eeee. Model Number: CDS985355C, UPC Number: 019348931018; Model Number: CDS985355D, UPC Number: 019348944277; Model Number: CDS985355F, UPC Number: 019532724262; Model Number: DYNJ900293J, UPC Number: 019348991514; Model Number: DYNJ902554I, UPC Number: 019348921874; Model Number: DYNJ902704P, UPC Number: 019348986337; Model Number: DYNJ904397D, UPC Number: 019348970120; Model Number: DYNJ904397F, UPC Number: 019348997971; Model Number: DYNJ906021B, UPC Number: 019348941129; Model Number: DYNJ906883A, UPC Number: 019348939820; Model Number: DYNJ909007, UPC Number: 019532724004; Model Number: DYNJ909091, UPC Number: 019532726860.   ffff. Model Number: DYNJ59796C, UPC Number: 019348990421.   gggg. Model Number: DYNJ81022, UPC Number: 019532708278.   hhhh. Model Number: DYNDA2526, UPC Number: 019348919179.   iiii. Model Number: DYNJ52606C, UPC Number: 019348973825; Model Number: DYNJ52606D, UPC Number: 019348981280; Model Number: DYNJ52606F, UPC Number: 019348934329.   jjjj. Model Number: DYNJ905285C, UPC Number: 019348994725.   kkkk. Model Number: DYNJ44420C, UPC Number: 019348959033; Model Number: DYNJ82698, UPC Number: 019532720300.   llll. Model Number: DYNJ82109, UPC Number: 019532717124.   mmmm. Model Number: DYNJ902259B, UPC Number: 019348991971.   nnnn. Model Number: DYNJ904984, UPC Number: 088994278935, Model Number: DYNJ904984B, UPC Number: 019348981293.   oooo. Model Number: CDS983040J, UPC Number: 019348924185; Model Number: CDS983040K, UPC Number: 019348984199; Model Number: CDS983136F, UPC Number: 019348921152; Model Number: CDS983136G, UPC Number: 019532714892.   pppp. Model Number: CDS982751K, UPC Number: 019348982501.   qqqq. Model Number: CDS983390G, UPC Number: 019348982050; Model Number: CDS983390I, UPC Number: 019532710364; Model Number: CDS983390J, UPC Number: 019532720540.   rrrr. Model Number: DYNJ902261F, UPC Number: 019348927536; Model Number: DYNJ902261G, UPC Number: 019348991972; Model Number: DYNJ905859, UPC Number: 019348954552.   ssss. Model Number: DYNJ37445I, UPC Number: 019348941739.   tttt. Model Number: DYNJ81023, UPC Number: 019532708279.   uuuu. Model Number: DYNJ53433F, UPC Number: 019348932867.   vvvv. Model Number: DYNJ81200, UPC Number: 019532709169; Model Number: DYNJ81200A, UPC Number: 019532722471.   wwww. Model Number: DYNJ81642A, UPC Number: 019532726638.   xxxx. Model Number: DYNJVB91050A, UPC Number: 019532717172.   yyyy. Model Number: DYNJ46100G, UPC Number: 019348926846; Model Number: DYNJ46100I, UPC Number: 019348985640.   zzzz. Model Number: DYNJ0103507AF, UPC Number: 019348956435; Model Number: DYNJ0103507AI, UPC Number: 019348956435; Model Number: DYNJ0103507AJ, UPC Number: 019532730242.. 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-2302-2023&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-2302-2023&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-2302-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2302-2023 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-2302-2023&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-2302-2023&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-2302-2023/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-2302-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2302-2023",
            "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: CDS840451L, UPC Number: 019532715163.   b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257.   c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365;  Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492.   d. Model Number: DYNJ53984G, UPC Number: 019532728288.   e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288.   f. Model Number: DYNJ0371669N, UPC Number: 019348923039.   g. Model Number: DYNJ22232W, UPC Number: 019532732560.   h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355.   i. Model Number: DYNJ901821A, UPC Number: 019532731932.   j. Model Number: DYNJ63153B, UPC Number: 019348984168.   k. Model Number: DYNJ63099F, UPC Number: 019532715003.   l. Model Number: DYNJ907858A, UPC Number: 019532713135.   m. Model Number: DYNJ62451, UPC Number: 019348965833.   n. Model Number: DYNJ906019C, UPC Number: 019348941128.   o. Model Number: DYNJ81295, UPC Number: 019532710670.   p. Model Number: DYNJ63069A, UPC Number: 019348942361.   q. Model Number: DYNJ60115B, UPC Number: 019532711880.   r. Model Number: NG340C, UPC Number: 019532730520.   s. Model Number: DYNJ905692D, UPC Number: 019532720229.   t. Model Number: DYNJ54750G, UPC Number: 019532702135.   u. Model Number: DYNJ35578G, UPC Number: 019348980860.   v. Model Number: CDS840487I, UPC Number: 019348944534.   w. Model Number: PAIN1423A, UPC Number: 019348920182.   x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F, UPC Number: 019348994461; Model Number: DYNJ901068I, UPC Number: 019532723251.   y. Model Number: SYNJ910022A, UPC Number: 019348937421; Model Number: SYNJ910022B, UPC Number: 019532700726; Model Number: SYNJ910022C, UPC Number: 019532735820.   z. Model Number: DYNJ82566, UPC Number: 019532719802.   aa. Model Number: DYNJ62007B, UPC Number: 019532716196.   bb. Model Number: PICCNC0010, UPC Number: 019532723117.   cc. Model Number: DYNJ45074C, UPC Number: 019348922267; Model Number: DYNJ61645A, UPC Number: 019348978134.   dd. Model Number: DYNJ61645A, UPC Number: 019348978134.   ee. Model Number: DYNJ54305, UPC Number: 088994247639.   ff. Model Number: DYNJ68990A, UPC Number: 019348998136.   gg. Model Number: DYNJ65775A, UPC Number: 019532714022.   hh. Model Number: DYNJ68492, UPC Number: 019348982724.   ii. Model Number: DYNJ43922, UPC Number: 088827707466; Model Number: DYNJ68968A, UPC Number: 019532720684; Model Number: DYNJ81618, UPC Number: 019532712460.   jj. Model Number: DYNJ66184, UPC Number: 019348932118.   kk. Model Number: DYNJ907554A, UPC Number: 019532702463; Model Number: DYNJ907554C, UPC Number: 019532718383.   ll. Model Number: DYNJ64601B, UPC Number: 019532728473.   mm. Model Number: DYNJ62197A, UPC Number: 019348999409; Model Number: DYNJ62197B, UPC Number: 019532716724.   nn. Model Number: DYNJ63341D, UPC Number: 019532727362.   oo. Model Number: DYNJ46549K, UPC Number: 019532700829; Model Number: DYNJ46549L, UPC Number: 019532729066.   pp. Model Number: DYNJ47660K, UPC Number: 019348987573.   qq. Model Number: DYNJ61894A, UPC Number: 019348973096.   rr. Model Number: DYNJ54287B, UPC Number: 019532716711.   ss. Model Number: DYNJ54265A, UPC Number: 019532715233.   tt. Model Number: DYNJ54285B, UPC Number: 019532714203.   uu. Model Number: DYNJ54286B, UPC Number: 019532714578.   vv. Model Number: DYNJ0565558U, UPC Number: 019348982703.   ww. Model Number: DYNJ40379D, UPC Number: 019348925761.   xx. Model Number: DYNJ55757C, UPC Number: 019532711653.   yy. Model Number: DYNJ33544J, UPC Number: 019348956435; Model Number: DYNJ33544K, UPC Number: 019348956435; Model Number: DYNJ33544L, UPC Number: 019532727931.   zz. Model Number: DYNJ908074B, UPC Number: 019532717268.   aaa. Model Number: DYNJ63817, UPC Number: 019348976395.   bbb. Model Number: DYNJ906102D, UPC Number: 019348982234; Model Number: DYNJ906102F, UPC Number: 019532702826.   ccc. Model Number: DYNJ83521, UPC Number: 019532727464.   ddd. Model Number: DYNJ65418, UPC Number: 019348927371.   eee. Model Number: DYNJ82314, UPC Number: 019532718421.   fff. Model Number: DYNJ49833I, UPC Number: 019348988536.   ggg. Model Number: DYNJ20031C, UPC Number: 088438965007.   hhh.  Model Number: DYNJ80918, UPC Number: 019532708492.   iii. Model Number: DYNJ908563, UPC Number: 019532708642.   jjj. Model Number: DYNJ80506, UPC Number: 019532704917.   kkk. Model Number: DYNJ69009, UPC Number: 019348987684; Model Number: DYNJ69009A, UPC Number: 019532707556.   lll. Model Number: DYNJ54014B, UPC Number: 088994276032.   mmm. Model Number: DYNJ43861F, UPC Number: 019348998164.   nnn. Model Number: DYNJ48153F, UPC Number: 019348998969.   ooo. Model Number: DYNJ43777J, UPC Number: 019348999018.   ppp. Model Number: DYNJ57539B, UPC Number: 019348930066; Model Number: DYNJ907561, UPC Number: 019348982123; Model Number: DYNJ907561A, UPC Number: 019532702884; Model Number: DYNJ908646, UPC Number: 019532712395;  Model Number: DYNJ908646A, UPC Number: 019532731496.   qqq. Model Number: DYNJ904401C, UPC Number: 019348934891; Model Number: DYNJ905859, UPC Number: 019348954552.   rrr. Model Number: DYNJ52766A, UPC Number: 019348929236; Model Number: DYNJ62915B, UPC Number: 019348936535; Model Number: DYNJ63340A, UPC Number: 019532727358; Model Number: DYNJ66769, UPC Number: 019348938052; Model Number: DYNJ68933, UPC Number: 019348986037; Model Number: DYNJ81095, UPC Number: 019532708412; Model Number: DYNJ82863A, UPC Number: 019532724504.   sss. Model Number: DYNJ66152A, UPC Number: 019348982021; Model Number: DYNJ66152B, UPC Number: 019532709042.   ttt. Model Number: DYNJ906391D, UPC Number: 019532702147.   uuu. Model Number: DYNJ903919J, UPC Number: 019532704590; Model Number: DYNJ903919K, UPC Number: 019532721878; Model Number: DYNJ903919L, UPC Number: 019532726705.   vvv. Model Number: DYNJ64449, UPC Number: 019348920157.   www. Model Number: TVS4000L, UPC Number: 019532722354.   xxx. Model Number: DYNJ55427B, UPC Number: 019348978611; Model Number: DYNJ55427C, UPC Number: 019532712656; Model Number: DYNJ55427D, UPC Number: 019532727261.   yyy. Model Number: DYNJ907201, UPC Number: 019348935833; Model Number: DYNJ907201B, UPC Number: 019348994665.   zzz. Model Number: DYNJ69622, UPC Number: 019348995958.   aaaa. Model Number: DYNJ69302, UPC Number: 019348992627.   bbbb. Model Number: DYNJ81705, UPC Number: 019532713557.   cccc. Model Number: DYNJ906882A, UPC Number: 019348939123.   dddd. Model Number: DYNJ58915, UPC Number: 088994290385; Model Number: DYNJ65842, UPC Number: 019348929631.   eeee. Model Number: CDS985355C, UPC Number: 019348931018; Model Number: CDS985355D, UPC Number: 019348944277; Model Number: CDS985355F, UPC Number: 019532724262; Model Number: DYNJ900293J, UPC Number: 019348991514; Model Number: DYNJ902554I, UPC Number: 019348921874; Model Number: DYNJ902704P, UPC Number: 019348986337; Model Number: DYNJ904397D, UPC Number: 019348970120; Model Number: DYNJ904397F, UPC Number: 019348997971; Model Number: DYNJ906021B, UPC Number: 019348941129; Model Number: DYNJ906883A, UPC Number: 019348939820; Model Number: DYNJ909007, UPC Number: 019532724004; Model Number: DYNJ909091, UPC Number: 019532726860.   ffff. Model Number: DYNJ59796C, UPC Number: 019348990421.   gggg. Model Number: DYNJ81022, UPC Number: 019532708278.   hhhh. Model Number: DYNDA2526, UPC Number: 019348919179.   iiii. Model Number: DYNJ52606C, UPC Number: 019348973825; Model Number: DYNJ52606D, UPC Number: 019348981280; Model Number: DYNJ52606F, UPC Number: 019348934329.   jjjj. Model Number: DYNJ905285C, UPC Number: 019348994725.   kkkk. Model Number: DYNJ44420C, UPC Number: 019348959033; Model Number: DYNJ82698, UPC Number: 019532720300.   llll. Model Number: DYNJ82109, UPC Number: 019532717124.   mmmm. Model Number: DYNJ902259B, UPC Number: 019348991971.   nnnn. Model Number: DYNJ904984, UPC Number: 088994278935, Model Number: DYNJ904984B, UPC Number: 019348981293.   oooo. Model Number: CDS983040J, UPC Number: 019348924185; Model Number: CDS983040K, UPC Number: 019348984199; Model Number: CDS983136F, UPC Number: 019348921152; Model Number: CDS983136G, UPC Number: 019532714892.   pppp. Model Number: CDS982751K, UPC Number: 019348982501.   qqqq. Model Number: CDS983390G, UPC Number: 019348982050; Model Number: CDS983390I, UPC Number: 019532710364; Model Number: CDS983390J, UPC Number: 019532720540.   rrrr. Model Number: DYNJ902261F, UPC Number: 019348927536; Model Number: DYNJ902261G, UPC Number: 019348991972; Model Number: DYNJ905859, UPC Number: 019348954552.   ssss. Model Number: DYNJ37445I, UPC Number: 019348941739.   tttt. Model Number: DYNJ81023, UPC Number: 019532708279.   uuuu. Model Number: DYNJ53433F, UPC Number: 019348932867.   vvvv. Model Number: DYNJ81200, UPC Number: 019532709169; Model Number: DYNJ81200A, UPC Number: 019532722471.   wwww. Model Number: DYNJ81642A, UPC Number: 019532726638.   xxxx. Model Number: DYNJVB91050A, UPC Number: 019532717172.   yyyy. Model Number: DYNJ46100G, UPC Number: 019348926846; Model Number: DYNJ46100I, UPC Number: 019348985640.   zzzz. Model Number: DYNJ0103507AF, UPC Number: 019348956435; Model Number: DYNJ0103507AI, UPC Number: 019348956435; Model Number: DYNJ0103507AJ, UPC Number: 019532730242.",
            "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"
          }
        }
      ]
    }
  ]
}