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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0157-2025.jsonld",
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  "name": "Medline brand medical procedure convenience kits, labeled as:    a) KIT LINE INSERTION, REF CVI4730A;   b) KIT LINE INSERTION, REF CVI4730A;   c) LINE INSERTION TRAY, REF DYNJ20803D;   d) CENTRAL LINE PACK-LF, REF DYNJ28368;   e) CENTRAL LINE PACK-LF, REF DYNJ28368;   f) PICC PACK-LF, REF DYNJ28487;   g) PICC PACK-LF, REF DYNJ28487H;   h) CENTRAL LINE PACK, REF DYNJ30087C;   i) CENTRAL LINE ADULT PACK, REF DYNJ35352;   j) PICC PACK, REF DYNJ52255;   k) PICC PROCEDURE PACK, REF DYNJ59067A;   l) PICC PROCEDURE PACK, REF DYNJ59067A;   m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;   n) PICC TEAM PACK, REF DYNJ64542A;   o) PICC LINE INSERTION PACK, REF DYNJ65519;   p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   r) PICC PACK, REF DYNJ69088A;   s) PICC INSERTION TRAY, REF DYNJ80031;   t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;   u) CVR ENDOVENOUS PACK, REF DYNJ80643;   v) RADIAL ARTERY PACK, REF DYNJ83938;",
  "description": "FDA recall Z-0157-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:    a) KIT LINE INSERTION, REF CVI4730A;   b) KIT LINE INSERTION, REF CVI4730A;   c) LINE INSERTION TRAY, REF DYNJ20803D;   d) CENTRAL LINE PACK-LF, REF DYNJ28368;   e) CENTRAL LINE PACK-LF, REF DYNJ28368;   f) PICC PACK-LF, REF DYNJ28487;   g) PICC PACK-LF, REF DYNJ28487H;   h) CENTRAL LINE PACK, REF DYNJ30087C;   i) CENTRAL LINE ADULT PACK, REF DYNJ35352;   j) PICC PACK, REF DYNJ52255;   k) PICC PROCEDURE PACK, REF DYNJ59067A;   l) PICC PROCEDURE PACK, REF DYNJ59067A;   m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;   n) PICC TEAM PACK, REF DYNJ64542A;   o) PICC LINE INSERTION PACK, REF DYNJ65519;   p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   r) PICC PACK, REF DYNJ69088A;   s) PICC INSERTION TRAY, REF DYNJ80031;   t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;   u) CVR ENDOVENOUS PACK, REF DYNJ80643;   v) RADIAL ARTERY PACK, REF DYNJ83938; (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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    "@type": "schema:MedicalDevice",
    "name": "Medline brand medical procedure convenience kits, labeled as:    a) KIT LINE INSERTION, REF CVI4730A;   b) KIT LINE INSERTION, REF CVI4730A;   c) LINE INSERTION TRAY, REF DYNJ20803D;   d) CENTRAL LINE PACK-LF, REF DYNJ28368;   e) CENTRAL LINE PACK-LF, REF DYNJ28368;   f) PICC PACK-LF, REF DYNJ28487;   g) PICC PACK-LF, REF DYNJ28487H;   h) CENTRAL LINE PACK, REF DYNJ30087C;   i) CENTRAL LINE ADULT PACK, REF DYNJ35352;   j) PICC PACK, REF DYNJ52255;   k) PICC PROCEDURE PACK, REF DYNJ59067A;   l) PICC PROCEDURE PACK, REF DYNJ59067A;   m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;   n) PICC TEAM PACK, REF DYNJ64542A;   o) PICC LINE INSERTION PACK, REF DYNJ65519;   p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   r) PICC PACK, REF DYNJ69088A;   s) PICC INSERTION TRAY, REF DYNJ80031;   t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;   u) CVR ENDOVENOUS PACK, REF DYNJ80643;   v) RADIAL ARTERY PACK, REF DYNJ83938;",
    "manufacturer": {
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0157-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0157-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:    a) KIT LINE INSERTION, REF CVI4730A;   b) KIT LINE INSERTION, REF CVI4730A;   c) LINE INSERTION TRAY, REF DYNJ20803D;   d) CENTRAL LINE PACK-LF, REF DYNJ28368;   e) CENTRAL LINE PACK-LF, REF DYNJ28368;   f) PICC PACK-LF, REF DYNJ28487;   g) PICC PACK-LF, REF DYNJ28487H;   h) CENTRAL LINE PACK, REF DYNJ30087C;   i) CENTRAL LINE ADULT PACK, REF DYNJ35352;   j) PICC PACK, REF DYNJ52255;   k) PICC PROCEDURE PACK, REF DYNJ59067A;   l) PICC PROCEDURE PACK, REF DYNJ59067A;   m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;   n) PICC TEAM PACK, REF DYNJ64542A;   o) PICC LINE INSERTION PACK, REF DYNJ65519;   p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   r) PICC PACK, REF DYNJ69088A;   s) PICC INSERTION TRAY, REF DYNJ80031;   t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;   u) CVR ENDOVENOUS PACK, REF DYNJ80643;   v) RADIAL ARTERY PACK, REF DYNJ83938;",
      "text": "The FDA logged enforcement record Z-0157-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline brand medical procedure convenience kits, labeled as:    a) KIT LINE INSERTION, REF CVI4730A;   b) KIT LINE INSERTION, REF CVI4730A;   c) LINE INSERTION TRAY, REF DYNJ20803D;   d) CENTRAL LINE PACK-LF, REF DYNJ28368;   e) CENTRAL LINE PACK-LF, REF DYNJ28368;   f) PICC PACK-LF, REF DYNJ28487;   g) PICC PACK-LF, REF DYNJ28487H;   h) CENTRAL LINE PACK, REF DYNJ30087C;   i) CENTRAL LINE ADULT PACK, REF DYNJ35352;   j) PICC PACK, REF DYNJ52255;   k) PICC PROCEDURE PACK, REF DYNJ59067A;   l) PICC PROCEDURE PACK, REF DYNJ59067A;   m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;   n) PICC TEAM PACK, REF DYNJ64542A;   o) PICC LINE INSERTION PACK, REF DYNJ65519;   p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;   r) PICC PACK, REF DYNJ69088A;   s) PICC INSERTION TRAY, REF DYNJ80031;   t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;   u) CVR ENDOVENOUS PACK, REF DYNJ80643;   v) RADIAL ARTERY PACK, REF DYNJ83938; — reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-04. Affected lots/codes: a) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers:  24ABK903;  b) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers:  23LBN351;  c) REF DYNJ20803D, UDI/DI 40889942553885 (each), 10889942553884 (case), Lot Numbers:  24ABE939;  d) REF DYNJ28368, UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers:  24ABD995;  e) REF DYNJ28368, UDI/DI UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers:  23KBE939;  f) REF DYNJ28487, UDI/DI 40080196227021 (each), 10080196227020 (case), Lot Numbers:  24ABI626;  g) REF DYNJ28487H, UDI/DI40080196227021 (each), 10080196227020 (case), Lot Numbers:  24ABI626;  h) REF DYNJ30087C, UDI/DI 40889942754145 (each), 10889942754144 (case), Lot Numbers:  23JBS113;  i) REF DYNJ35352, UDI/DI 40884389433080 (each), 10884389433089 (case), Lot Numbers:  23LBN154;  j) REF DYNJ52255, UDI/DI 40889942253709 (each), 10889942253708 (case), Lot Numbers:  24ABC063;  k) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers:  24ABC903;  l) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers:  23LBM072;  m) REF DYNJ61247A, UDI/DI 40195327492862 (each), 10195327492861 (case), Lot Numbers:  23LBN198;  n) REF DYNJ64542A, UDI/DI 40193489293723 (each), 0193489293722 (case), Lot Numbers:  23LBN027;  o) REF DYNJ65519, UDI/DI 40193489283939 (each), 10193489283938 (case), Lot Numbers:  24ABE345;  p) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers:  24ABH428;  q) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers:  23LBT018;  r) REF DYNJ69088A, UDI/DI 40193489975247 (each), 10193489975246 (case), Lot Numbers:  23LBP745;  s) REF DYNJ80031, UDI/DI 40195327007745 (each), 10195327007744 (case), Lot Numbers:  23LBN003;  t) REF DYNJ80489A, UDI/DI 40195327582723 (each), 10195327582722 (case), Lot Numbers:  23LBP033;  u) REF DYNJ80643, UDI/DI 40195327055791 (each), 10195327055790 (case), Lot Numbers:  23KBK131;  v) REF DYNJ83938, UDI/DI 40195327317233 (each), 101953273172329 (case), Lot Numbers:  24ABG864. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0157-2025&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-0157-2025&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-0157-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0157-2025 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
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      "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-0157-2025&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-0157-2025&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-0157-2025/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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      "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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      "name": "FDA recall details — Z-0157-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0157-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-09-04",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers:  24ABK903;  b) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers:  23LBN351;  c) REF DYNJ20803D, UDI/DI 40889942553885 (each), 10889942553884 (case), Lot Numbers:  24ABE939;  d) REF DYNJ28368, UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers:  24ABD995;  e) REF DYNJ28368, UDI/DI UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers:  23KBE939;  f) REF DYNJ28487, UDI/DI 40080196227021 (each), 10080196227020 (case), Lot Numbers:  24ABI626;  g) REF DYNJ28487H, UDI/DI40080196227021 (each), 10080196227020 (case), Lot Numbers:  24ABI626;  h) REF DYNJ30087C, UDI/DI 40889942754145 (each), 10889942754144 (case), Lot Numbers:  23JBS113;  i) REF DYNJ35352, UDI/DI 40884389433080 (each), 10884389433089 (case), Lot Numbers:  23LBN154;  j) REF DYNJ52255, UDI/DI 40889942253709 (each), 10889942253708 (case), Lot Numbers:  24ABC063;  k) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers:  24ABC903;  l) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers:  23LBM072;  m) REF DYNJ61247A, UDI/DI 40195327492862 (each), 10195327492861 (case), Lot Numbers:  23LBN198;  n) REF DYNJ64542A, UDI/DI 40193489293723 (each), 0193489293722 (case), Lot Numbers:  23LBN027;  o) REF DYNJ65519, UDI/DI 40193489283939 (each), 10193489283938 (case), Lot Numbers:  24ABE345;  p) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers:  24ABH428;  q) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers:  23LBT018;  r) REF DYNJ69088A, UDI/DI 40193489975247 (each), 10193489975246 (case), Lot Numbers:  23LBP745;  s) REF DYNJ80031, UDI/DI 40195327007745 (each), 10195327007744 (case), Lot Numbers:  23LBN003;  t) REF DYNJ80489A, UDI/DI 40195327582723 (each), 10195327582722 (case), Lot Numbers:  23LBP033;  u) REF DYNJ80643, UDI/DI 40195327055791 (each), 10195327055790 (case), Lot Numbers:  23KBK131;  v) REF DYNJ83938, UDI/DI 40195327317233 (each), 101953273172329 (case), Lot Numbers:  24ABG864",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}