{
  "@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-2323-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871",
  "description": "FDA recall Z-2323-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871 (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-2323-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2323-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2323-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871",
      "text": "The FDA logged enforcement record Z-2323-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871 — 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: DYNDA2482, UPC Number: 10193489198188.   b. Model Number: ART920, UPC Number: 10653160327899.   c. Model Number: DT19810, UPC Number: 10653160285656.   d. Model Number: CVI4915, UPC Number: 10653160355489.   e. Model Number: IVS3770, UPC Number: 10653160328230.   f. Model Number: DYNDV2407A, UPC Number: 019348981701.   g. Model Number: MID0005, UPC Number: 10653160349181.   h. Model Number: CVI4340, UPC Number: 10653160309475.   i. Model Number: MIDST04011, UPC Number: 10653160350699.   j. Model Number: MID0001, UPC Number: 10193489381627.   k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334.   l. Model Number: PICC0009A, UPC Number: 10193489760231.   m. Model Number: DYNJ80152MB, UPC Number: 10889942733422.   n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515.   o. Model Number: DYNDC2120B, UPC Number: 10193489198270.   p. Model Number: CVI3740A, UPC Number: 10653160324416.   q. Model Number: IVS3990, UPC Number: 10653160345282.   r. Model Number: CVI4450B, UPC Number: 10653160358428.   s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436.   t. Model Number: PICC0013, UPC Number: 10653160351818.   u. Model Number: DT14560, UPC Number: 10653160236887.   v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509.   w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491.   x. Model Number: DYNJ70152MB, UPC Number: 10889942722822.   y. Model Number: BSIPIV1010, UPC Number: 10653160356523.   z. Model Number: BSIPIV1004, UPC Number: 10193489198843.   aa. Model Number: DYNJ68937A, UPC Number: 10193489111545.   bb. Model Number: CVI3700, UPC Number: 10653160259763.   cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391.   dd. Model Number: IVS3350, UPC Number: 10653160313045.   ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246.   ff. Model Number: BSIPIV1006, UPC Number: 10653160356936.   gg. Model Number: DYNDV2385, UPC Number: 10193489195217.   hh. Model Number: IVS4075, UPC Number: 10653160350545.    ii. Model Number: BSIPIV1011, UPC Number: 10653160353317.   jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335.   kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142.   ll. Model Number: IVS3715, UPC Number: 10653160326298.   mm. Model Number: IV8790, UPC Number: 019348936055.   nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858.   oo. Model Number: IVS3970, UPC Number: 10653160343431.   pp. Model Number: CVI3910, UPC Number: 10653160272311.   qq. Model Number: DT16125, UPC Number: 10653160254751.   rr. Model Number: DYNDV2435, UPC Number: 019532704366.   ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455.   tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482.   uu. Model Number: DYNDV2578, UPC Number: 10653160358374.   vv. Model Number: IVS3910, UPC Number: 10653160338871.   ww. Model Number: CVI3880, UPC Number: 10653160272755.   xx. Model Number: STCVC2020A, UPC Number: 10653160350569.   yy. Model Number: STCVC2015A, UPC Number: 10653160350552.   zz. Model Number: DYNJ64871, UPC Number: 019348922536.. 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-2323-2023&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-2323-2023&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-2323-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2323-2023 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-2323-2023&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-2323-2023&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-2323-2023/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-2323-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2323-2023",
            "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: DYNDA2482, UPC Number: 10193489198188.   b. Model Number: ART920, UPC Number: 10653160327899.   c. Model Number: DT19810, UPC Number: 10653160285656.   d. Model Number: CVI4915, UPC Number: 10653160355489.   e. Model Number: IVS3770, UPC Number: 10653160328230.   f. Model Number: DYNDV2407A, UPC Number: 019348981701.   g. Model Number: MID0005, UPC Number: 10653160349181.   h. Model Number: CVI4340, UPC Number: 10653160309475.   i. Model Number: MIDST04011, UPC Number: 10653160350699.   j. Model Number: MID0001, UPC Number: 10193489381627.   k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334.   l. Model Number: PICC0009A, UPC Number: 10193489760231.   m. Model Number: DYNJ80152MB, UPC Number: 10889942733422.   n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515.   o. Model Number: DYNDC2120B, UPC Number: 10193489198270.   p. Model Number: CVI3740A, UPC Number: 10653160324416.   q. Model Number: IVS3990, UPC Number: 10653160345282.   r. Model Number: CVI4450B, UPC Number: 10653160358428.   s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436.   t. Model Number: PICC0013, UPC Number: 10653160351818.   u. Model Number: DT14560, UPC Number: 10653160236887.   v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509.   w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491.   x. Model Number: DYNJ70152MB, UPC Number: 10889942722822.   y. Model Number: BSIPIV1010, UPC Number: 10653160356523.   z. Model Number: BSIPIV1004, UPC Number: 10193489198843.   aa. Model Number: DYNJ68937A, UPC Number: 10193489111545.   bb. Model Number: CVI3700, UPC Number: 10653160259763.   cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391.   dd. Model Number: IVS3350, UPC Number: 10653160313045.   ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246.   ff. Model Number: BSIPIV1006, UPC Number: 10653160356936.   gg. Model Number: DYNDV2385, UPC Number: 10193489195217.   hh. Model Number: IVS4075, UPC Number: 10653160350545.    ii. Model Number: BSIPIV1011, UPC Number: 10653160353317.   jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335.   kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142.   ll. Model Number: IVS3715, UPC Number: 10653160326298.   mm. Model Number: IV8790, UPC Number: 019348936055.   nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858.   oo. Model Number: IVS3970, UPC Number: 10653160343431.   pp. Model Number: CVI3910, UPC Number: 10653160272311.   qq. Model Number: DT16125, UPC Number: 10653160254751.   rr. Model Number: DYNDV2435, UPC Number: 019532704366.   ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455.   tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482.   uu. Model Number: DYNDV2578, UPC Number: 10653160358374.   vv. Model Number: IVS3910, UPC Number: 10653160338871.   ww. Model Number: CVI3880, UPC Number: 10653160272755.   xx. Model Number: STCVC2020A, UPC Number: 10653160350569.   yy. Model Number: STCVC2015A, UPC Number: 10653160350552.   zz. Model Number: DYNJ64871, UPC Number: 019348922536.",
            "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"
          }
        }
      ]
    }
  ]
}