{
  "@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-2299-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;    b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900;   c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US;   d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US;    e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A;   f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A;   g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US;    h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A;   i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935;   j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US;   k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670;   l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090;    m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930;   n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US;   o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I;   p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010;    q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615;   r. OR ANGIO PACK, Model Number: DYNJ59184B;   s. OR ANGIOGRAM, Model Number: DYNJ909267;   t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D;   u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B;   v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D;   w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665;   x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A;   y. PACK CARDIAC CATH, Model Number: DYNJ65481;   z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B;   aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I;   bb.  PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K;   cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C;   dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D;   ee. PERMA CATH PACK, Model Number: DYNJ62007A;    ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665;   gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190;      hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380;   ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655;   jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650;   kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660;   ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685;    mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F;   nn. PK, RADIOLOGY, Model Number: DYNJ43894B;   oo. PORT A CATH PACK, Model Number: DYNJ59307F;   pp. PORT PACK, Model Number: DYNJ58162;   qq. PORTACATH PACK, Model Number: DYNJ51240A;   rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700;   ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995;   tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135;   uu. QUAD LUMEN KIT, Model Number: ECVC5820;   vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913;   ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C;   xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000;   yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B;   zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835;      aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030;   bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041;   ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729;   ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G;   eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C;    fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R;   ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C;   hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A;   iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A;    jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810",
  "description": "FDA recall Z-2299-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;    b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900;   c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US;   d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US;    e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A;   f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A;   g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US;    h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A;   i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935;   j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US;   k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670;   l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090;    m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930;   n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US;   o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I;   p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010;    q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615;   r. OR ANGIO PACK, Model Number: DYNJ59184B;   s. OR ANGIOGRAM, Model Number: DYNJ909267;   t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D;   u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B;   v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D;   w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665;   x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A;   y. PACK CARDIAC CATH, Model Number: DYNJ65481;   z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B;   aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I;   bb.  PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K;   cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C;   dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D;   ee. PERMA CATH PACK, Model Number: DYNJ62007A;    ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665;   gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190;      hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380;   ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655;   jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650;   kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660;   ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685;    mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F;   nn. PK, RADIOLOGY, Model Number: DYNJ43894B;   oo. PORT A CATH PACK, Model Number: DYNJ59307F;   pp. PORT PACK, Model Number: DYNJ58162;   qq. PORTACATH PACK, Model Number: DYNJ51240A;   rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700;   ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995;   tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135;   uu. QUAD LUMEN KIT, Model Number: ECVC5820;   vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913;   ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C;   xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000;   yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B;   zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835;      aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030;   bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041;   ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729;   ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G;   eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C;    fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R;   ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C;   hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A;   iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A;    jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810 (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-2299-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;    b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900;   c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US;   d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US;    e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A;   f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A;   g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US;    h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A;   i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935;   j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US;   k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670;   l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090;    m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930;   n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US;   o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I;   p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010;    q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615;   r. OR ANGIO PACK, Model Number: DYNJ59184B;   s. OR ANGIOGRAM, Model Number: DYNJ909267;   t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D;   u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B;   v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D;   w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665;   x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A;   y. PACK CARDIAC CATH, Model Number: DYNJ65481;   z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B;   aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I;   bb.  PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K;   cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C;   dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D;   ee. PERMA CATH PACK, Model Number: DYNJ62007A;    ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665;   gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190;      hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380;   ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655;   jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650;   kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660;   ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685;    mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F;   nn. PK, RADIOLOGY, Model Number: DYNJ43894B;   oo. PORT A CATH PACK, Model Number: DYNJ59307F;   pp. PORT PACK, Model Number: DYNJ58162;   qq. PORTACATH PACK, Model Number: DYNJ51240A;   rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700;   ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995;   tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135;   uu. QUAD LUMEN KIT, Model Number: ECVC5820;   vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913;   ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C;   xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000;   yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B;   zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835;      aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030;   bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041;   ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729;   ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G;   eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C;    fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R;   ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C;   hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A;   iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A;    jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2299-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2299-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;    b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900;   c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US;   d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US;    e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A;   f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A;   g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US;    h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A;   i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935;   j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US;   k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670;   l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090;    m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930;   n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US;   o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I;   p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010;    q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615;   r. OR ANGIO PACK, Model Number: DYNJ59184B;   s. OR ANGIOGRAM, Model Number: DYNJ909267;   t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D;   u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B;   v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D;   w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665;   x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A;   y. PACK CARDIAC CATH, Model Number: DYNJ65481;   z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B;   aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I;   bb.  PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K;   cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C;   dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D;   ee. PERMA CATH PACK, Model Number: DYNJ62007A;    ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665;   gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190;      hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380;   ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655;   jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650;   kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660;   ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685;    mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F;   nn. PK, RADIOLOGY, Model Number: DYNJ43894B;   oo. PORT A CATH PACK, Model Number: DYNJ59307F;   pp. PORT PACK, Model Number: DYNJ58162;   qq. PORTACATH PACK, Model Number: DYNJ51240A;   rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700;   ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995;   tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135;   uu. QUAD LUMEN KIT, Model Number: ECVC5820;   vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913;   ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C;   xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000;   yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B;   zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835;      aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030;   bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041;   ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729;   ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G;   eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C;    fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R;   ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C;   hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A;   iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A;    jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810",
      "text": "The FDA logged enforcement record Z-2299-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;    b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900;   c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US;   d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US;    e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A;   f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A;   g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US;    h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A;   i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935;   j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US;   k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670;   l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090;    m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930;   n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US;   o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I;   p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010;    q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615;   r. OR ANGIO PACK, Model Number: DYNJ59184B;   s. OR ANGIOGRAM, Model Number: DYNJ909267;   t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D;   u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B;   v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D;   w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665;   x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A;   y. PACK CARDIAC CATH, Model Number: DYNJ65481;   z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B;   aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I;   bb.  PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K;   cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C;   dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D;   ee. PERMA CATH PACK, Model Number: DYNJ62007A;    ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665;   gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190;      hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380;   ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655;   jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650;   kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660;   ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685;    mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F;   nn. PK, RADIOLOGY, Model Number: DYNJ43894B;   oo. PORT A CATH PACK, Model Number: DYNJ59307F;   pp. PORT PACK, Model Number: DYNJ58162;   qq. PORTACATH PACK, Model Number: DYNJ51240A;   rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700;   ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995;   tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135;   uu. QUAD LUMEN KIT, Model Number: ECVC5820;   vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913;   ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C;   xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000;   yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B;   zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835;      aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030;   bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041;   ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729;   ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G;   eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C;    fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R;   ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C;   hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A;   iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A;    jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810 — 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: ECVC475, UPC Number: 10653160333081.   b. Model Number: ECVC3900, UPC Number: 10653160334828.   c. Model Number: STCVC20US, UPC Number: 10653160339076.   d. Model Number: STCVC21US, UPC Number: 10653160339045.   e. Model Number: ECVC6585A, UPC Number: 10653160338826.   f. Model Number: ECVC7235A, UPC Number: 10653160354550.   g. Model Number: STCVC03US, UPC Number: 10653160339212.   h. Model Number: ECVC6655A, UPC Number:10653160339267.   i. Model Number: ECVC7935, UPC Number: 10653160353669.   j. Model Number: STCVC04US, UPC Number: 10653160339199.   k. Model Number: ECVC7670, UPC Number:10653160348054.   l. Model Number: ECVC7090, UPC Number: 10653160339243.   m. Model Number: ECVC6930, UPC Number:10653160339250.    n. Model Number: STCVC13US, UPC Number: 10653160339137.   o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712.   p. Model Number: ECVC8010, UPC Number: 10653160356356.   q. Model Number: ECVC4615, UPC Number: 10653160336075.   r. Model Number: DYNJ59184B, UPC Number: 019348994910.   s. Model Number: DYNJ909267, UPC Number: 019532731461.   t. Model Number: DYNJ906297D, UPC Number: 019532714128.   u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222.   v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047.   w.  Model Number: ECVC6665, UPC Number: 10653160337843.   x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001.   y. Model Number: DYNJ65481, UPC Number: 019348928046.   z. Model Number: DYNJ60112B, UPC Number: 019532711884.   aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126.   bb.  Model Number: DYNJ0843244K, UPC Number: 019532728859.   cc. Model Number: DYNJ57645C, UPC Number:019532728741.   dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364.    ee. Model Number: DYNJ62007A, UPC Number: 019348987890.   ff. Model Number: ECVC3665, UPC Number: 10653160336044.    gg. Model Number: ECVC6190, UPC Number: 10653160337751.   hh. Model Number: ECVC4380, UPC Number: 10653160338147.   ii. Model Number: ECVC5655, UPC Number: 10653160337621.   jj. Model Number: ECVC5650, UPC Number: 10653160336457.   kk. Model Number: ECVC5660, UPC Number: 10653160337638.   ll. Model Number: ECVC5685, UPC Number: 10653160337652.   mm. Model Number: DYNJ0275614F, UPC Number: 088994217434.   nn. Model Number: DYNJ43894B, UPC Number: 019348981048.   oo. Model Number: DYNJ59307F, UPC Number: 019532705885.   pp. Model Number: DYNJ58162, UPC Number: 088994282933.   qq. Model Number: DYNJ51240A, UPC Number: 088994249352.   rr. Model Number: ECVC3700, UPC Number: 10653160332886.   ss. Model Number: ECVC4995, UPC Number: 10653160335283.   tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900.   uu. Model Number: ECVC5820, UPC Number: 10653160338123.   vv. Model Number: DYNJ65913, UPC Number: 019348930317.   ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290.   xx. Model Number: DYNJVB1000, UPC Number: 019348980099.   yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688.   zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364.   aaa. Model Number: DYNJ82030, UPC Number: 019532716237.   bbb. Model Number: DYNJ82041, UPC Number: 019532716221.   ccc. Model Number: DYNJ68729, UPC Number: 019348983654.   ddd. Model Number: DYNJ38314G, UPC Number: 019348960334.     eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094.   fff. Model Number: DYNJ0604508R, UPC Number: 019348982844.   ggg. Model Number: DYNJ23288C, UPC Number: 019348995414.   hhh.  Model Number: DYNJ67136A, UPC Number: 019348993567.   iii. Model Number: ECVC7465A, UPC Number: 10653160350088.   jjj. Model Number: ECVC8100, UPC Number: 10653160357841.   kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118.   lll. Model Number: DYNJ80925, UPC Number: 019532708511.   mmm. Model Number: DYNJ52425J, UPC Number: 019348994014.   nnn. Model Number: DYNJ83251, UPC Number: 019532724865.   ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792.   ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116.   qqq. Model Number: ECVC5015, UPC Number: 10653160338956.   rrr. Model Number: ECVC3395, UPC Number: 10653160338635.    sss. Model Number: ECVC5810, UPC Number: 10653160336419.   ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150.   uuu. Model Number: ECVC825A, UPC Number: 10653160333548.   vvv. Model Number: ECVC7180, UPC Number: 10653160343165.   www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701.   xxx. Model Number: ECVC7290, UPC Number: 10653160344933.   yyy. Model Number: ECVC5355B, UPC Number: 10653160357742.   zzz. Model Number: ECVC6020A, UPC Number: 10653160338413.   aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383.   bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849.   cccc. Model Number: ECVC6540, UPC Number: 10653160339397.   dddd. Model Number: ECVC3735A, UPC Number: 10653160334798.   eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372.    ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794.   gggg. Model Number: ECVC1710, UPC Number: 10653160332268.   hhhh. Model Number: ECVC5815, UPC Number: 10653160336402.   iiii. Model Number: DYNJ67990A, UPC Number: 019532726533.   jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108.    kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812.   llll. Model Number: ECVC1655, UPC Number: 10653160254935.   mmmm. Model Number: ECVC7170, UPC Number: 10653160333524.   nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164.   oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617.   pppp. Model Number: ECVC7970, UPC Number: 10653160353980.   qqqq. Model Number: ECVC6815, UPC Number: 10653160335115.   rrrr. Model Number: ECVC6840, UPC Number: 10653160336761.   ssss. Model Number: ECVC6835, UPC Number: 10653160336778.   tttt. Model Number: ECVC7485, UPC Number: 10653160354802.   uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153.    vvvv. Model Number: ECVC6630, UPC Number: 10653160337492.   wwww. Model Number: ECVC6690, UPC Number: 10653160336600.    xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404.   yyyy. Model Number: ECVC7915, UPC Number: 10653160353355.   zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366.   aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601.   bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966.   ccccc. Model Number: ECVC7625, UPC Number: 10653160356295.   ddddd. Model Number: ECVC7895, UPC Number: 10653160355328.   eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589.   fffff. Model Number: ECVC7405, UPC Number: 10653160347132.   ggggg. Model Number: ECVC7295, UPC Number: 10653160344650.   hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839.   iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748.   jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698.   kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905.  lllll. Model Number: ECVC8025, UPC Number: 10653160355434.   mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700.   nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682.   ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342.   ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565.   qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750.   rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804.   sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375.   ttttt. Model Number: ECVC5595, UPC Number: 10653160336495.   uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092.   vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365.   wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631.   xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853.   yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359.   zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899.   aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314.   bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795.   cccccc. Model Number: ECVC6255, UPC Number: 10653160336525.   dddddd. Model Number: ECVC6260, UPC Number: 10653160336488.   eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690.   ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399.   gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679.   hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835.   iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038.   jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950.   kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.. 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-2299-2023&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-2299-2023&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-2299-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2299-2023 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-2299-2023&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-2299-2023&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-2299-2023/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-2299-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2299-2023",
            "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: ECVC475, UPC Number: 10653160333081.   b. Model Number: ECVC3900, UPC Number: 10653160334828.   c. Model Number: STCVC20US, UPC Number: 10653160339076.   d. Model Number: STCVC21US, UPC Number: 10653160339045.   e. Model Number: ECVC6585A, UPC Number: 10653160338826.   f. Model Number: ECVC7235A, UPC Number: 10653160354550.   g. Model Number: STCVC03US, UPC Number: 10653160339212.   h. Model Number: ECVC6655A, UPC Number:10653160339267.   i. Model Number: ECVC7935, UPC Number: 10653160353669.   j. Model Number: STCVC04US, UPC Number: 10653160339199.   k. Model Number: ECVC7670, UPC Number:10653160348054.   l. Model Number: ECVC7090, UPC Number: 10653160339243.   m. Model Number: ECVC6930, UPC Number:10653160339250.    n. Model Number: STCVC13US, UPC Number: 10653160339137.   o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712.   p. Model Number: ECVC8010, UPC Number: 10653160356356.   q. Model Number: ECVC4615, UPC Number: 10653160336075.   r. Model Number: DYNJ59184B, UPC Number: 019348994910.   s. Model Number: DYNJ909267, UPC Number: 019532731461.   t. Model Number: DYNJ906297D, UPC Number: 019532714128.   u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222.   v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047.   w.  Model Number: ECVC6665, UPC Number: 10653160337843.   x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001.   y. Model Number: DYNJ65481, UPC Number: 019348928046.   z. Model Number: DYNJ60112B, UPC Number: 019532711884.   aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126.   bb.  Model Number: DYNJ0843244K, UPC Number: 019532728859.   cc. Model Number: DYNJ57645C, UPC Number:019532728741.   dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364.    ee. Model Number: DYNJ62007A, UPC Number: 019348987890.   ff. Model Number: ECVC3665, UPC Number: 10653160336044.    gg. Model Number: ECVC6190, UPC Number: 10653160337751.   hh. Model Number: ECVC4380, UPC Number: 10653160338147.   ii. Model Number: ECVC5655, UPC Number: 10653160337621.   jj. Model Number: ECVC5650, UPC Number: 10653160336457.   kk. Model Number: ECVC5660, UPC Number: 10653160337638.   ll. Model Number: ECVC5685, UPC Number: 10653160337652.   mm. Model Number: DYNJ0275614F, UPC Number: 088994217434.   nn. Model Number: DYNJ43894B, UPC Number: 019348981048.   oo. Model Number: DYNJ59307F, UPC Number: 019532705885.   pp. Model Number: DYNJ58162, UPC Number: 088994282933.   qq. Model Number: DYNJ51240A, UPC Number: 088994249352.   rr. Model Number: ECVC3700, UPC Number: 10653160332886.   ss. Model Number: ECVC4995, UPC Number: 10653160335283.   tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900.   uu. Model Number: ECVC5820, UPC Number: 10653160338123.   vv. Model Number: DYNJ65913, UPC Number: 019348930317.   ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290.   xx. Model Number: DYNJVB1000, UPC Number: 019348980099.   yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688.   zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364.   aaa. Model Number: DYNJ82030, UPC Number: 019532716237.   bbb. Model Number: DYNJ82041, UPC Number: 019532716221.   ccc. Model Number: DYNJ68729, UPC Number: 019348983654.   ddd. Model Number: DYNJ38314G, UPC Number: 019348960334.     eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094.   fff. Model Number: DYNJ0604508R, UPC Number: 019348982844.   ggg. Model Number: DYNJ23288C, UPC Number: 019348995414.   hhh.  Model Number: DYNJ67136A, UPC Number: 019348993567.   iii. Model Number: ECVC7465A, UPC Number: 10653160350088.   jjj. Model Number: ECVC8100, UPC Number: 10653160357841.   kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118.   lll. Model Number: DYNJ80925, UPC Number: 019532708511.   mmm. Model Number: DYNJ52425J, UPC Number: 019348994014.   nnn. Model Number: DYNJ83251, UPC Number: 019532724865.   ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792.   ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116.   qqq. Model Number: ECVC5015, UPC Number: 10653160338956.   rrr. Model Number: ECVC3395, UPC Number: 10653160338635.    sss. Model Number: ECVC5810, UPC Number: 10653160336419.   ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150.   uuu. Model Number: ECVC825A, UPC Number: 10653160333548.   vvv. Model Number: ECVC7180, UPC Number: 10653160343165.   www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701.   xxx. Model Number: ECVC7290, UPC Number: 10653160344933.   yyy. Model Number: ECVC5355B, UPC Number: 10653160357742.   zzz. Model Number: ECVC6020A, UPC Number: 10653160338413.   aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383.   bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849.   cccc. Model Number: ECVC6540, UPC Number: 10653160339397.   dddd. Model Number: ECVC3735A, UPC Number: 10653160334798.   eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372.    ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794.   gggg. Model Number: ECVC1710, UPC Number: 10653160332268.   hhhh. Model Number: ECVC5815, UPC Number: 10653160336402.   iiii. Model Number: DYNJ67990A, UPC Number: 019532726533.   jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108.    kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812.   llll. Model Number: ECVC1655, UPC Number: 10653160254935.   mmmm. Model Number: ECVC7170, UPC Number: 10653160333524.   nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164.   oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617.   pppp. Model Number: ECVC7970, UPC Number: 10653160353980.   qqqq. Model Number: ECVC6815, UPC Number: 10653160335115.   rrrr. Model Number: ECVC6840, UPC Number: 10653160336761.   ssss. Model Number: ECVC6835, UPC Number: 10653160336778.   tttt. Model Number: ECVC7485, UPC Number: 10653160354802.   uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153.    vvvv. Model Number: ECVC6630, UPC Number: 10653160337492.   wwww. Model Number: ECVC6690, UPC Number: 10653160336600.    xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404.   yyyy. Model Number: ECVC7915, UPC Number: 10653160353355.   zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366.   aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601.   bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966.   ccccc. Model Number: ECVC7625, UPC Number: 10653160356295.   ddddd. Model Number: ECVC7895, UPC Number: 10653160355328.   eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589.   fffff. Model Number: ECVC7405, UPC Number: 10653160347132.   ggggg. Model Number: ECVC7295, UPC Number: 10653160344650.   hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839.   iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748.   jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698.   kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905.  lllll. Model Number: ECVC8025, UPC Number: 10653160355434.   mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700.   nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682.   ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342.   ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565.   qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750.   rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804.   sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375.   ttttt. Model Number: ECVC5595, UPC Number: 10653160336495.   uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092.   vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365.   wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631.   xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853.   yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359.   zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899.   aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314.   bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795.   cccccc. Model Number: ECVC6255, UPC Number: 10653160336525.   dddddd. Model Number: ECVC6260, UPC Number: 10653160336488.   eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690.   ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399.   gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679.   hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835.   iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038.   jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950.   kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.",
            "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"
          }
        }
      ]
    }
  ]
}