{
  "@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-2321-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA",
  "description": "FDA recall Z-2321-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA (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-2321-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2321-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2321-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA",
      "text": "The FDA logged enforcement record Z-2321-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA — 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: DYNJ54755B, UPC Number: 088994292536.   b. Model Number: DYNJ40306A, UPC Number: 088994260192.   c. Model Number: DYNJ0774759P, UPC Number: 019532724613.   d. Model Number: DYNJ902261D, UPC Number: 088994275524.   e. Model Number: DYNJRA1747, UPC Number: 019348946400.   f. Model Number: DYNJ44960D, UPC Number: 019348983324.   g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443.   h. Model Number: DYNJ904401B, UPC Number: 019348968343.   i. Model Number: DYNJ42262D, UPC Number: 088994269795.   j. Model Number: DYNJ47502B, UPC Number: 019348964922.   k. Model Number: DYNJ67414, UPC Number: 019348996464.   l. Model Number: PHS41739A, UPC Number: 088994290680.   m. Model Number: DYNJ60038, UPC Number: 088827779327.   n. Model Number: CDS982858F, UPC Number: 088827773921.   o. Model Number: DYNJ39885A, UPC Number: 088994253993.   p. Model Number: DYNJ41873B, UPC Number: 019348956306.   q. Model Number: DYNJ52688A, UPC Number: 088994284356.   r. Model Number: CDS982859F, UPC Number: 088827773920.   s. Model Number: DYNJ47717, UPC Number: 088827751458.   t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847.   u. Model Number: DYNJ59067, UPC Number: 088994293004.   v. Model Number: DYNJ49177F, UPC Number: 088827777434.   w. Model Number: DYNDC2399A, UPC Number: 088994244693.   x. Model Number: DYNJ41114C, UPC Number: 019532726173.   y. Model Number: DYNJ54894A, UPC Number: 019348921355.   z. Model Number: DYNJ54894A, UPC Number: 019348921355.   aa. Model Number: DYNJ54982A, UPC Number: 019348980895.   bb. Model Number: CVI4765, UPC Number: 019348995318.   cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261.   dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176.   ee. Model Number: DYNJ64393, UPC Number: 019348980963.   ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827.   gg. Model Number: DYNJRA1498, UPC Number: 019348979574.  hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039.    ii. Model Number: CDS984329J, UPC Number: 088994286535.   jj. Model Number: DYNJ62197, UPC Number: 019348963300.   kk. Model Number: DYNJ45757F, UPC Number: 088827779258.   ll. Model Number: DYNJ46549J, UPC Number: 019348933778.   mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680.   nn. Model Number: DYNJ60698B, UPC Number: 019532706789.   oo. Model Number: DYNJ63155A, UPC Number: 019348931402.   pp. Model Number: DYNJ42172A, UPC Number: 019348950271.   qq. Model Number: DYNJ58225B, UPC Number: 088827777898.   rr. Model Number: PHS479840M, UPC Number: 019348968272.   ss. Model Number: MNS11625, UPC Number: 065316032213.   tt. Model Number: DYNJ41114B, UPC Number: 088994269269.   uu. Model Number: DYNJRA1256, UPC Number: 019348951155.   vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449.   ww. Model Number: DYNJ40379C, UPC Number: 088994281455.   xx. Model Number: DYNJ906112, UPC Number: 019348965663.   yy. Model Number: DYNJ60009A, UPC Number: 019348964887.   zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705.   aaa. Model Number: DYNJ33546J, UPC Number: 019348956435.   bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373.   ccc. Model Number: DYNJ62434A, UPC Number: 019348936627.   ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542.   eee. Model Number: CDS984584L, UPC Number: 088994270130.   fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843.   ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435.   hhh. Model Number: DYNJ67504A, UPC Number: 019532700961.   iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064.   jjj. Model Number: DYNJ64027, UPC Number: 019348977993.   kkk. Model Number: DYNJ49833J, UPC Number: 019532705946.   lll. Model Number: DYNDA2805, UPC Number: 019348984614.   mmm. Model Number: DYNJRA0958, UPC Number: 088994261890.   nnn. Model Number: DYNJ48153C, UPC Number: 088994276562.   ooo. Model Number: DYNJ43777G, UPC Number: 088994291573.   ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061.   qqq. Model Number: DYNJ53319C, UPC Number: 019348963449.   rrr. Model Number: DYNJ63340, UPC Number: 019348974116.   sss. Model Number: DYNJ906391B, UPC Number: 019348981688.   ttt. Model Number: DYNDH1190, UPC Number: 088994249424.   uuu. Model Number: DYKM2125, UPC Number: 019532704487.   vvv. Model Number: DYNJ58424, UPC Number: 088994285183.   www. Model Number: DYNJ37099C, UPC Number: 019348956435.   xxx. Model Number: DYNJ59062, UPC Number: 088994294165.   yyy. Model Number: TVS4300A, UPC Number: 081698202335.   zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356.   aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353.   bbbb. Model Number: DYNDV2537, UPC Number: 019532718408.   cccc. Model Number: DYNDC2099, UPC Number: 088827729567.   dddd. Model Number: DYNJ56535, UPC Number: 088994265334.   eeee. Model Number: DYNDH1319, UPC Number: 088994279547.   ffff. Model Number: DYNDV2385A, UPC Number: 019532729876.   gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673.   hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305.   iiii. Model Number: IVS3820, UPC Number: 065316034231.   jjjj. Model Number: DYNDV2371, UPC Number: 019348943086.   kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168.   llll. Model Number: DYNDH1112, UPC Number: 10889942277360.   mmmm. Model Number: IV8635D, UPC Number: 065316099026.   nnnn. Model Number: DYNDV2502, UPC Number: 019532701409.   oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835.   pppp. Model Number: DYNJ61433, UPC Number: 019348956517.   qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007.   rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956.   ssss. Model Number: DYNDH1492, UPC Number: 019348943446.   tttt. Model Number: DYNJ904401B, UPC Number: 019348968343.   uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654.   vvvv. Model Number: CDS982895I, UPC Number: 088994220768.   wwww. Model Number: DYNJ902261D, UPC Number: 088994275524.   xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775.   yyyy. Model Number: VC-PK, UPC Number: 019532717689.   zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744.  aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925.   bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200.   ccccc. Model Number: DYNJS3005, UPC Number: 088438909956.   ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768.   eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563.   fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447.   ggggg. Model Number: DYNJ59631, UPC Number: 088827776402.   hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850.   iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435.   jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970.   kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856.   lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435.   mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982.   nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726.   ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951.   ppppp. Model Number: DYNJ59246, UPC Number: 088827776729.   qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453.   rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466.   sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.. 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-2321-2023&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-2321-2023&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-2321-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2321-2023 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-2321-2023&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-2321-2023&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-2321-2023/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-2321-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2321-2023",
            "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: DYNJ54755B, UPC Number: 088994292536.   b. Model Number: DYNJ40306A, UPC Number: 088994260192.   c. Model Number: DYNJ0774759P, UPC Number: 019532724613.   d. Model Number: DYNJ902261D, UPC Number: 088994275524.   e. Model Number: DYNJRA1747, UPC Number: 019348946400.   f. Model Number: DYNJ44960D, UPC Number: 019348983324.   g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443.   h. Model Number: DYNJ904401B, UPC Number: 019348968343.   i. Model Number: DYNJ42262D, UPC Number: 088994269795.   j. Model Number: DYNJ47502B, UPC Number: 019348964922.   k. Model Number: DYNJ67414, UPC Number: 019348996464.   l. Model Number: PHS41739A, UPC Number: 088994290680.   m. Model Number: DYNJ60038, UPC Number: 088827779327.   n. Model Number: CDS982858F, UPC Number: 088827773921.   o. Model Number: DYNJ39885A, UPC Number: 088994253993.   p. Model Number: DYNJ41873B, UPC Number: 019348956306.   q. Model Number: DYNJ52688A, UPC Number: 088994284356.   r. Model Number: CDS982859F, UPC Number: 088827773920.   s. Model Number: DYNJ47717, UPC Number: 088827751458.   t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847.   u. Model Number: DYNJ59067, UPC Number: 088994293004.   v. Model Number: DYNJ49177F, UPC Number: 088827777434.   w. Model Number: DYNDC2399A, UPC Number: 088994244693.   x. Model Number: DYNJ41114C, UPC Number: 019532726173.   y. Model Number: DYNJ54894A, UPC Number: 019348921355.   z. Model Number: DYNJ54894A, UPC Number: 019348921355.   aa. Model Number: DYNJ54982A, UPC Number: 019348980895.   bb. Model Number: CVI4765, UPC Number: 019348995318.   cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261.   dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176.   ee. Model Number: DYNJ64393, UPC Number: 019348980963.   ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827.   gg. Model Number: DYNJRA1498, UPC Number: 019348979574.  hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039.    ii. Model Number: CDS984329J, UPC Number: 088994286535.   jj. Model Number: DYNJ62197, UPC Number: 019348963300.   kk. Model Number: DYNJ45757F, UPC Number: 088827779258.   ll. Model Number: DYNJ46549J, UPC Number: 019348933778.   mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680.   nn. Model Number: DYNJ60698B, UPC Number: 019532706789.   oo. Model Number: DYNJ63155A, UPC Number: 019348931402.   pp. Model Number: DYNJ42172A, UPC Number: 019348950271.   qq. Model Number: DYNJ58225B, UPC Number: 088827777898.   rr. Model Number: PHS479840M, UPC Number: 019348968272.   ss. Model Number: MNS11625, UPC Number: 065316032213.   tt. Model Number: DYNJ41114B, UPC Number: 088994269269.   uu. Model Number: DYNJRA1256, UPC Number: 019348951155.   vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449.   ww. Model Number: DYNJ40379C, UPC Number: 088994281455.   xx. Model Number: DYNJ906112, UPC Number: 019348965663.   yy. Model Number: DYNJ60009A, UPC Number: 019348964887.   zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705.   aaa. Model Number: DYNJ33546J, UPC Number: 019348956435.   bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373.   ccc. Model Number: DYNJ62434A, UPC Number: 019348936627.   ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542.   eee. Model Number: CDS984584L, UPC Number: 088994270130.   fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843.   ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435.   hhh. Model Number: DYNJ67504A, UPC Number: 019532700961.   iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064.   jjj. Model Number: DYNJ64027, UPC Number: 019348977993.   kkk. Model Number: DYNJ49833J, UPC Number: 019532705946.   lll. Model Number: DYNDA2805, UPC Number: 019348984614.   mmm. Model Number: DYNJRA0958, UPC Number: 088994261890.   nnn. Model Number: DYNJ48153C, UPC Number: 088994276562.   ooo. Model Number: DYNJ43777G, UPC Number: 088994291573.   ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061.   qqq. Model Number: DYNJ53319C, UPC Number: 019348963449.   rrr. Model Number: DYNJ63340, UPC Number: 019348974116.   sss. Model Number: DYNJ906391B, UPC Number: 019348981688.   ttt. Model Number: DYNDH1190, UPC Number: 088994249424.   uuu. Model Number: DYKM2125, UPC Number: 019532704487.   vvv. Model Number: DYNJ58424, UPC Number: 088994285183.   www. Model Number: DYNJ37099C, UPC Number: 019348956435.   xxx. Model Number: DYNJ59062, UPC Number: 088994294165.   yyy. Model Number: TVS4300A, UPC Number: 081698202335.   zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356.   aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353.   bbbb. Model Number: DYNDV2537, UPC Number: 019532718408.   cccc. Model Number: DYNDC2099, UPC Number: 088827729567.   dddd. Model Number: DYNJ56535, UPC Number: 088994265334.   eeee. Model Number: DYNDH1319, UPC Number: 088994279547.   ffff. Model Number: DYNDV2385A, UPC Number: 019532729876.   gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673.   hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305.   iiii. Model Number: IVS3820, UPC Number: 065316034231.   jjjj. Model Number: DYNDV2371, UPC Number: 019348943086.   kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168.   llll. Model Number: DYNDH1112, UPC Number: 10889942277360.   mmmm. Model Number: IV8635D, UPC Number: 065316099026.   nnnn. Model Number: DYNDV2502, UPC Number: 019532701409.   oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835.   pppp. Model Number: DYNJ61433, UPC Number: 019348956517.   qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007.   rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956.   ssss. Model Number: DYNDH1492, UPC Number: 019348943446.   tttt. Model Number: DYNJ904401B, UPC Number: 019348968343.   uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654.   vvvv. Model Number: CDS982895I, UPC Number: 088994220768.   wwww. Model Number: DYNJ902261D, UPC Number: 088994275524.   xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775.   yyyy. Model Number: VC-PK, UPC Number: 019532717689.   zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744.  aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925.   bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200.   ccccc. Model Number: DYNJS3005, UPC Number: 088438909956.   ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768.   eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563.   fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447.   ggggg. Model Number: DYNJ59631, UPC Number: 088827776402.   hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850.   iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435.   jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970.   kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856.   lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435.   mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982.   nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726.   ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951.   ppppp. Model Number: DYNJ59246, UPC Number: 088827776729.   qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453.   rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466.   sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.",
            "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"
          }
        }
      ]
    }
  ]
}