{
  "@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-2223-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES\tD684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)\tD684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES\tD684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\tD684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)\tD684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES\tD684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)\tD684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)\tD684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY\tD684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs \tD884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs\tD884-00-0019-13",
  "description": "FDA recall Z-2223-2023 — Datascope Corp. is recalling LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES\tD684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)\tD684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES\tD684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\tD684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)\tD684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES\tD684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)\tD684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)\tD684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY\tD684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs \tD884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs\tD884-00-0019-13 (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-2223-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES\tD684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)\tD684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES\tD684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\tD684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)\tD684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES\tD684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)\tD684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)\tD684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY\tD684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs \tD884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs\tD884-00-0019-13",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Datascope Corp."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2223-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2223-2023: Datascope Corp. is recalling LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES\tD684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)\tD684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES\tD684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\tD684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)\tD684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES\tD684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)\tD684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)\tD684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY\tD684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs \tD884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs\tD884-00-0019-13",
      "text": "The FDA logged enforcement record Z-2223-2023: Datascope Corp. is voluntarily recalling LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES\tD684-00-0479-01  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)\tD684-00-0479-02  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0479-01C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0479-02C  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0479-07  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0479-08  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0479-09  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0479-10  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0479-01U  LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0479-02U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES\tD684-00-0480-01  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\tD684-00-0480-02  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0480-01C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA)\tD684-00-0480-02C  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0480-07  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA)\tD684-00-0480-08  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0480-09  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0480-10  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0480-01U  LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0480-02U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES\tD684-00-0478-01  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA)\tD684-00-0478-02  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0478-01C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA)\tD684-00-0478-02C  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0478-07  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0478-08  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0478-09  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0478-10  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0478-01U  LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY\tD684-00-0478-02U  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs \tD884-00-0019-12  PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs\tD884-00-0019-13 — reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-23. Affected lots/codes: Product Description                                                    UDI LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES 10605767106557 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) 10605767106540 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10605767109329 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) 10605767109336 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10605767109695 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) 10605767109701 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) 10605767113180 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10605767113142 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10605767109503 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY 10605767109510 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567106564 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567106571 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109343 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) 10607567109350 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109718 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) 10607567109725 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113197 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113159 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109527 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109534 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES 10607567106526 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) 10607567106533 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) 10607567109305 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) 10607567109312 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) 10607567109671 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109688 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) 10607567113203 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113210 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY 10607567109480 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY 10607567109497 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs  10607567106632 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs 10607567106649. 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-2223-2023&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-2223-2023&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-2223-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2223-2023 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-2223-2023&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-2223-2023&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-2223-2023/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-2223-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2223-2023",
            "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": "Datascope Corp.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-06-23",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Description                                                    UDI LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES 10605767106557 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) 10605767106540 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10605767109329 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) 10605767109336 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10605767109695 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) 10605767109701 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) 10605767113180 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10605767113142 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10605767109503 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY 10605767109510 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567106564 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567106571 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109343 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) 10607567109350 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109718 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) 10607567109725 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113197 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113159 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109527 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109534 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES 10607567106526 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) 10607567106533 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) 10607567109305 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) 10607567109312 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) 10607567109671 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109688 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) 10607567113203 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113210 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY 10607567109480 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY 10607567109497 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs  10607567106632 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs 10607567106649",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic distribution nationwide. International distribution worldwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}