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  "name": "Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;    (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;    (11)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;    (12)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;    (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;    (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and     (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.",
  "description": "FDA recall Z-3299-2024 — ARROW INTERNATIONAL Inc. is recalling Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;    (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;    (11)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;    (12)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;    (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;    (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and     (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4. (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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    "@type": "schema:MedicalDevice",
    "name": "Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;    (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;    (11)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;    (12)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;    (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;    (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and     (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.",
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      "name": "ARROW INTERNATIONAL Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3299-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3299-2024: ARROW INTERNATIONAL Inc. is recalling Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;    (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;    (11)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;    (12)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;    (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;    (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and     (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.",
      "text": "The FDA logged enforcement record Z-3299-2024: ARROW INTERNATIONAL Inc. is voluntarily recalling Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021\" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;    (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;    (11)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;    (12)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;    (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;    (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and     (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4. — reason: Reports have been received regarding open seals on the packaging.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-26. Affected lots/codes: (1) REF ASK-04001-BW1:  Batch numbers 33F23M0157, 33F24C0002, 33F24C0136, and 33F23L0297, UDI-DI:  10801902117585;  (2) REF ASK-04001-CK:  Batch numbers 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, and 33F23L0738, UDI-DI: 00801902091215;   (3) REF ASK-04001-VAMC1:  Batch numbers 33F24A0825 and 33F24B0235, UDI-DI: 10801902158854;  (4) REF ASK-04020-BHS:  Batch numbers 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, and 33F23L0687, UDI-DI: 30801902144578;  (5) REF ASK-04020-BID:  Batch number 33F23J0777, UDI (1)10801902211429(17)260331(10)33F23J0777;  (6) REF ASK-04020-HMC:  Batch numbers 33F24A0743, 33F23L0747, and 33F24A1129, UDI-DI: 10801902117691;  (7) REF ASK-04020-HOA:  Batch number 33F24D0969, UDI: (1)10801902214802(17)251124(10)33F24D0969;  (8) REF ASK-04020-KSD:  Batch number 33F24D0964, UDI: (1)10801902219630(17)251130(10)33F24D0964;  (9) REF ASK-04020-LOL: Batch numbers 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, and 33F23M0033, UDI-DI 10801902144765;  (10) REF ASK-04020-MHS: Batch numbers 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, and 33F23L0734, UDI-DI 20801902117711(17)260426;  (11) REF ASK-04020-MIB3: Batch number 33F24A0901, UDI (1)10801902206401(17)250831(10)33F24A0901;  (12) REF ASK-04020-PRH:  Batch number 33F23K0602, UDI (1)10801902155938(17)250731(10)33F23K0602;  (13) REF ASK-04020-UOIL:  Batch number 33F24B0001, UDI (1)10801902218978(17)261031(10)33F24B0001;  (14) REF ASK-04220-KSP:  Batch number 33F23L0323, UDI (1)10801902156409(17)250531(10)33F23L0323; and  (15) REF ASK-04500-HFH4:  Batch numbers 33F24C0436, 33F24A0617, and 33F23K1006, UDI-DI 10801902200461.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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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-3299-2024&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-3299-2024&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-3299-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3299-2024 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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      "epistemicStatus": {
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        "supported": true,
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        "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-3299-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3299-2024/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,
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        "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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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "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": "ARROW INTERNATIONAL Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Reports have been received regarding open seals on the packaging.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-07-26",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "(1) REF ASK-04001-BW1:  Batch numbers 33F23M0157, 33F24C0002, 33F24C0136, and 33F23L0297, UDI-DI:  10801902117585;  (2) REF ASK-04001-CK:  Batch numbers 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, and 33F23L0738, UDI-DI: 00801902091215;   (3) REF ASK-04001-VAMC1:  Batch numbers 33F24A0825 and 33F24B0235, UDI-DI: 10801902158854;  (4) REF ASK-04020-BHS:  Batch numbers 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, and 33F23L0687, UDI-DI: 30801902144578;  (5) REF ASK-04020-BID:  Batch number 33F23J0777, UDI (1)10801902211429(17)260331(10)33F23J0777;  (6) REF ASK-04020-HMC:  Batch numbers 33F24A0743, 33F23L0747, and 33F24A1129, UDI-DI: 10801902117691;  (7) REF ASK-04020-HOA:  Batch number 33F24D0969, UDI: (1)10801902214802(17)251124(10)33F24D0969;  (8) REF ASK-04020-KSD:  Batch number 33F24D0964, UDI: (1)10801902219630(17)251130(10)33F24D0964;  (9) REF ASK-04020-LOL: Batch numbers 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, and 33F23M0033, UDI-DI 10801902144765;  (10) REF ASK-04020-MHS: Batch numbers 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, and 33F23L0734, UDI-DI 20801902117711(17)260426;  (11) REF ASK-04020-MIB3: Batch number 33F24A0901, UDI (1)10801902206401(17)250831(10)33F24A0901;  (12) REF ASK-04020-PRH:  Batch number 33F23K0602, UDI (1)10801902155938(17)250731(10)33F23K0602;  (13) REF ASK-04020-UOIL:  Batch number 33F24B0001, UDI (1)10801902218978(17)261031(10)33F24B0001;  (14) REF ASK-04220-KSP:  Batch number 33F23L0323, UDI (1)10801902156409(17)250531(10)33F23L0323; and  (15) REF ASK-04500-HFH4:  Batch numbers 33F24C0436, 33F24A0617, and 33F23K1006, UDI-DI 10801902200461.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV.  There was government distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}