{
  "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": "88312",
      "product_res_number": "Z-0866-2010",
      "event_date_initiated": "2010-01-20",
      "event_date_posted": "2010-02-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-06",
      "res_event_number": "54355",
      "product_code": "DSY",
      "k_numbers": [
        "K052964"
      ],
      "product_description": "EXXCEL Soft Standard Wall EPTFE Vascular Graft;\nD:8 mm: L: 50 mm straight\nMaquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470",
      "code_info": "Product Code: M002004910580; Lot # 12633379, Exp: 4/2012",
      "firm_fei_number": "2242352",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "additional_info_contact": "Dennis Genito\n973-709-7515",
      "reason_for_recall": "Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts.  Bleeding could occur if wrong product is used.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.",
      "product_quantity": "18 units",
      "distribution_pattern": "Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.",
      "openfda": {
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        "pma_number": [
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        "registration_number": [
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        "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3450",
        "device_class": "2"
      }
    }
  ]
}