{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "31749",
      "product_res_number": "Z-0762-04",
      "event_date_initiated": "2003-07-28",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-04-06",
      "res_event_number": "28389",
      "product_code": "MGB",
      "pma_numbers": [
        "P920004"
      ],
      "product_description": "VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000.  Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits.  The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope.  The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths.  The device is indicated for use in sealing the femoral arterial puncture site.",
      "code_info": "Lot No. 0605374, Exp. Date May 2005.",
      "firm_fei_number": "3003071194",
      "recalling_firm": "Datascope Collagen Products Division",
      "address_1": "1300 MacArthur Blvd.",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-0605",
      "additional_info_contact": "Gina M. Crossetta\n201-995-8783",
      "reason_for_recall": "Kits are missing the temporary arteriotomy locator (TAL) from the blister package.",
      "root_cause_description": "Other",
      "action": "'Urgent Customer Advisory' Letter dated July 28, 2003.",
      "product_quantity": "1485 kits",
      "distribution_pattern": "The device was distributed throughout the US to 101 direct accounts.  There was one distributor.  There was one government account.",
      "openfda": {
        "pma_number": [
          "P100013",
          "P010049",
          "P150022",
          "P180025",
          "P210017",
          "P990037",
          "P040044",
          "P050043",
          "P150006",
          "P230038",
          "P050007",
          "P120016",
          "P040022",
          "P960043",
          "P920004",
          "P080029",
          "P020035",
          "P930038"
        ],
        "registration_number": [
          "3009984513",
          "1226183",
          "2011171",
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        ],
        "fei_number": [
          "3009984513",
          "2011171",
          "3005747797",
          "3001236277",
          "3012102437",
          "1721686",
          "3005718570",
          "3012977275",
          "3002924544",
          "3002757549",
          "3015145497",
          "3003898360",
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          "3010142363",
          "3002907620",
          "3003528016",
          "3005334138",
          "2246552",
          "1016427",
          "3002827704",
          "3007766601",
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          "3000215205",
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          "2243441",
          "3000215273",
          "3015542130",
          "3002807314",
          "3004635528",
          "3013394970"
        ],
        "device_name": "Device, Hemostasis, Vascular",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}