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  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;       b. ARTHOGRAM TRAY, Model Number: PAIN1524B;     c. ARTHROGRAM TRAY, Model Number: PAIN1524A;    d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A;       e. CRANIOTOMY CDS, Model Number: CDS981753L;       f. CRANIOTOMY CDS-1, Model Number: CDS982889I;       g. CRANIOTOMY PACK, Model Number: DYNJ61749A;       h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722;       i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E;       j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168;       k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169;       l. HYBRID PACK, Model Number: DYNJ56907D;       m. IR ARM PACK, Model Number: DYNJ50712C;       n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D;       o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A;       p. OASC IVF PACK, Model Number: DYNJ53035B;       q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619;       r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C;       s. SCO ARTHROSCOPY, Model Number: DYNJ906551A;       t. SHOULDER BLOCK KIT , Model Number: DYKS1241A;       u. SHOULDER PACK-LF, Model Number: PHS41748D;       v. TAA AAA, Model Number: DYNJ63339D;       w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L;       x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420;       y. TUNNEL PACK, Model Number: DYNJ58127B;       z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F;       aa. US JOINT KIT, Model Number: DYNJRA1944;       bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D,  DYNJ63373F;",
  "description": "FDA recall Z-2338-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;       b. ARTHOGRAM TRAY, Model Number: PAIN1524B;     c. ARTHROGRAM TRAY, Model Number: PAIN1524A;    d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A;       e. CRANIOTOMY CDS, Model Number: CDS981753L;       f. CRANIOTOMY CDS-1, Model Number: CDS982889I;       g. CRANIOTOMY PACK, Model Number: DYNJ61749A;       h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722;       i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E;       j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168;       k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169;       l. HYBRID PACK, Model Number: DYNJ56907D;       m. IR ARM PACK, Model Number: DYNJ50712C;       n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D;       o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A;       p. OASC IVF PACK, Model Number: DYNJ53035B;       q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619;       r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C;       s. SCO ARTHROSCOPY, Model Number: DYNJ906551A;       t. SHOULDER BLOCK KIT , Model Number: DYKS1241A;       u. SHOULDER PACK-LF, Model Number: PHS41748D;       v. TAA AAA, Model Number: DYNJ63339D;       w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L;       x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420;       y. TUNNEL PACK, Model Number: DYNJ58127B;       z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F;       aa. US JOINT KIT, Model Number: DYNJRA1944;       bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D,  DYNJ63373F; (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;       b. ARTHOGRAM TRAY, Model Number: PAIN1524B;     c. ARTHROGRAM TRAY, Model Number: PAIN1524A;    d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A;       e. CRANIOTOMY CDS, Model Number: CDS981753L;       f. CRANIOTOMY CDS-1, Model Number: CDS982889I;       g. CRANIOTOMY PACK, Model Number: DYNJ61749A;       h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722;       i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E;       j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168;       k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169;       l. HYBRID PACK, Model Number: DYNJ56907D;       m. IR ARM PACK, Model Number: DYNJ50712C;       n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D;       o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A;       p. OASC IVF PACK, Model Number: DYNJ53035B;       q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619;       r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C;       s. SCO ARTHROSCOPY, Model Number: DYNJ906551A;       t. SHOULDER BLOCK KIT , Model Number: DYKS1241A;       u. SHOULDER PACK-LF, Model Number: PHS41748D;       v. TAA AAA, Model Number: DYNJ63339D;       w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L;       x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420;       y. TUNNEL PACK, Model Number: DYNJ58127B;       z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F;       aa. US JOINT KIT, Model Number: DYNJRA1944;       bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D,  DYNJ63373F;",
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      "name": "FDA recall Z-2338-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;       b. ARTHOGRAM TRAY, Model Number: PAIN1524B;     c. ARTHROGRAM TRAY, Model Number: PAIN1524A;    d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A;       e. CRANIOTOMY CDS, Model Number: CDS981753L;       f. CRANIOTOMY CDS-1, Model Number: CDS982889I;       g. CRANIOTOMY PACK, Model Number: DYNJ61749A;       h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722;       i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E;       j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168;       k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169;       l. HYBRID PACK, Model Number: DYNJ56907D;       m. IR ARM PACK, Model Number: DYNJ50712C;       n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D;       o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A;       p. OASC IVF PACK, Model Number: DYNJ53035B;       q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619;       r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C;       s. SCO ARTHROSCOPY, Model Number: DYNJ906551A;       t. SHOULDER BLOCK KIT , Model Number: DYKS1241A;       u. SHOULDER PACK-LF, Model Number: PHS41748D;       v. TAA AAA, Model Number: DYNJ63339D;       w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L;       x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420;       y. TUNNEL PACK, Model Number: DYNJ58127B;       z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F;       aa. US JOINT KIT, Model Number: DYNJRA1944;       bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D,  DYNJ63373F;",
      "text": "The FDA logged enforcement record Z-2338-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;       b. ARTHOGRAM TRAY, Model Number: PAIN1524B;     c. ARTHROGRAM TRAY, Model Number: PAIN1524A;    d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A;       e. CRANIOTOMY CDS, Model Number: CDS981753L;       f. CRANIOTOMY CDS-1, Model Number: CDS982889I;       g. CRANIOTOMY PACK, Model Number: DYNJ61749A;       h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722;       i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E;       j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168;       k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169;       l. HYBRID PACK, Model Number: DYNJ56907D;       m. IR ARM PACK, Model Number: DYNJ50712C;       n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D;       o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A;       p. OASC IVF PACK, Model Number: DYNJ53035B;       q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619;       r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C;       s. SCO ARTHROSCOPY, Model Number: DYNJ906551A;       t. SHOULDER BLOCK KIT , Model Number: DYKS1241A;       u. SHOULDER PACK-LF, Model Number: PHS41748D;       v. TAA AAA, Model Number: DYNJ63339D;       w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L;       x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420;       y. TUNNEL PACK, Model Number: DYNJ58127B;       z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F;       aa. US JOINT KIT, Model Number: DYNJRA1944;       bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D,  DYNJ63373F; — 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: DYNJ65963A, UPC Number: 019348999205.   b. Model Number: PAIN1524B, UPC Number: 019348999446.   c. Model Number: PAIN1524A, UPC Number: 019348932800.   d. Model Number: DYNJ63149A, UPC Number: 019348978647.   e. Model Number: CDS981753L, UPC Number: 019532723862.   f. Model Number: CDS982889I, UPC Number: 088994220806.   g. Model Number: DYNJ61749A, UPC Number: 019532706301.   h. Model Number: DYNDH1722, UPC Number: 019532713216.   i. Model Number: OST011E, UPC Number: 088827758932.   j. Model Number: DYNJ909168, UPC Number: 019532728659.   k. Model Number: DYNJ909169, UPC Number: 019532728660.   l. Model Number: DYNJ56907D, UPC Number: 019348983156.   m. Model Number: DYNJ50712C, UPC Number: 019348987016.   n. Model Number: SPEC0204D, UPC Number: 019348930298.   o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677.   p. Model Number: DYNJ53035B, UPC Number: 088827776381.   q. Model Number: DYNJRA1619, UPC Number: 019348931184.    r. Model Number: PHS392881009C, UPC Number: 019348922233.   s. Model Number: DYNJ906551A, UPC Number: 019532712408.   t. Model Number: DYKS1241A, UPC Number: 019348948809.   u. Model Number: PHS41748D, UPC Number: 019348978479.   v. Model Number: DYNJ63339D, UPC Number: 019532727360.   w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130.   x. Model Number: DYNJ908420, UPC Number: 019532707336.   y. Model Number: DYNJ58127B, UPC Number: 019348948279.   z. Model Number: SPEC0205F, UPC Number: 019348921288.   aa. Model Number: DYNJRA1944, UPC Number: 019532713304.    bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
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        "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-2338-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2338-2023&lang=eng"
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      "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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2338-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2338-2023 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",
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        "value": "Class II",
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        }
      },
      "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-2338-2023/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
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      "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."
    }
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            "Status": "recorded"
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            "Status": "recorded"
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            "Field": "Classification",
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            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-05-15",
            "Status": "recorded"
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            "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: DYNJ65963A, UPC Number: 019348999205.   b. Model Number: PAIN1524B, UPC Number: 019348999446.   c. Model Number: PAIN1524A, UPC Number: 019348932800.   d. Model Number: DYNJ63149A, UPC Number: 019348978647.   e. Model Number: CDS981753L, UPC Number: 019532723862.   f. Model Number: CDS982889I, UPC Number: 088994220806.   g. Model Number: DYNJ61749A, UPC Number: 019532706301.   h. Model Number: DYNDH1722, UPC Number: 019532713216.   i. Model Number: OST011E, UPC Number: 088827758932.   j. Model Number: DYNJ909168, UPC Number: 019532728659.   k. Model Number: DYNJ909169, UPC Number: 019532728660.   l. Model Number: DYNJ56907D, UPC Number: 019348983156.   m. Model Number: DYNJ50712C, UPC Number: 019348987016.   n. Model Number: SPEC0204D, UPC Number: 019348930298.   o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677.   p. Model Number: DYNJ53035B, UPC Number: 088827776381.   q. Model Number: DYNJRA1619, UPC Number: 019348931184.    r. Model Number: PHS392881009C, UPC Number: 019348922233.   s. Model Number: DYNJ906551A, UPC Number: 019532712408.   t. Model Number: DYKS1241A, UPC Number: 019348948809.   u. Model Number: PHS41748D, UPC Number: 019348978479.   v. Model Number: DYNJ63339D, UPC Number: 019532727360.   w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130.   x. Model Number: DYNJ908420, UPC Number: 019532707336.   y. Model Number: DYNJ58127B, UPC Number: 019348948279.   z. Model Number: SPEC0205F, UPC Number: 019348921288.   aa. Model Number: DYNJRA1944, UPC Number: 019532713304.    bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.",
            "Status": "recorded"
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          "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"
          }
        }
      ]
    }
  ]
}