{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Merrimack",
      "state": "NH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81524",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "address_2": "N/A",
      "postal_code": "03054-4332",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.",
      "recall_number": "Z-0560-2019",
      "product_description": "Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128",
      "product_quantity": "2930 units",
      "reason_for_recall": "This recall has been initiated in response to a seal defect found in certain sterile barrier pouches  containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient.  A sterility breach could potentially lead to product contamination. The potentially affected device is  used in contact with critical anatomical structures and deep into the body. If contaminated, the  consequences for the patient could be severe. The severity of the possible clinical complications  depends on the degree of contamination of the device, the microorganisms involved and the patient s  risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this  issue.",
      "recall_initiation_date": "20181012",
      "center_classification_date": "20181206",
      "termination_date": "20200512",
      "report_date": "20181212",
      "code_info": "ME221275"
    }
  ]
}