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  "name": "Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:   Material Description (Material Number):  SSK H M C 20061890 (560074),  SSK S C H (560214),  SSK BJC H S (ORIGINAL CUST) (560272),  SSK CA P M C (ORIGINAL CUST) (560327),  SSK T M H (560394),  SSK S O 20070208 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672);",
  "description": "FDA recall Z-2278-2026 — B Braun Medical Inc is recalling Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:   Material Description (Material Number):  SSK H M C 20061890 (560074),  SSK S C H (560214),  SSK BJC H S (ORIGINAL CUST) (560272),  SSK CA P M C (ORIGINAL CUST) (560327),  SSK T M H (560394),  SSK S O 20070208 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672); (Devices, Class I). 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": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2278-2026&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:   Material Description (Material Number):  SSK H M C 20061890 (560074),  SSK S C H (560214),  SSK BJC H S (ORIGINAL CUST) (560272),  SSK CA P M C (ORIGINAL CUST) (560327),  SSK T M H (560394),  SSK S O 20070208 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672);",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "B Braun Medical Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2278-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2278-2026: B Braun Medical Inc is recalling Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:   Material Description (Material Number):  SSK H M C 20061890 (560074),  SSK S C H (560214),  SSK BJC H S (ORIGINAL CUST) (560272),  SSK CA P M C (ORIGINAL CUST) (560327),  SSK T M H (560394),  SSK S O 20070208 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672);",
      "text": "The FDA logged enforcement record Z-2278-2026: B Braun Medical Inc is voluntarily recalling Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:   Material Description (Material Number):  SSK H M C 20061890 (560074),  SSK S C H (560214),  SSK BJC H S (ORIGINAL CUST) (560272),  SSK CA P M C (ORIGINAL CUST) (560327),  SSK T M H (560394),  SSK S O 20070208 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672); — reason: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-05-06. Affected lots/codes: 1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565; 2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782; 3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330; 4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751; 5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313; 6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927; 7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772; 8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615; 9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361; 10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362; 11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766; 12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226; 13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321; 14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288; 15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771; 16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001; 17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090; 18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847; 19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579; 20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805; 21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285; 22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364; 23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374; 24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578; 25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313; 26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798;  27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460; 28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778; 29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394; 30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370; 31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801;  32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133; 33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803; 34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569; 35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783;. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "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-2278-2026&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-2278-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2278-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2278-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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,
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      "grounding": {
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        "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-2278-2026&lang=eng",
        "value": "Class I",
        "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-2278-2026&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-2278-2026/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."
    }
  ],
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      "name": "FDA recall details — Z-2278-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2278-2026",
            "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 I",
            "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": "B Braun Medical Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-05-06",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565; 2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782; 3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330; 4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751; 5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313; 6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927; 7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772; 8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615; 9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361; 10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362; 11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766; 12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226; 13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321; 14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288; 15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771; 16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001; 17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090; 18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847; 19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579; 20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805; 21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285; 22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364; 23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374; 24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578; 25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313; 26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798;  27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460; 28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778; 29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394; 30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370; 31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801;  32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133; 33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803; 34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569; 35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}