{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Merrimack",
      "state": "NH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91718",
      "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 and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.",
      "recall_number": "Z-1302-2023",
      "product_description": "Atrium Pneumostat Chest Drain Valve, Part Number 16100",
      "product_quantity": "3554 cases of 10",
      "reason_for_recall": "The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.",
      "recall_initiation_date": "20230301",
      "center_classification_date": "20230330",
      "report_date": "20230405",
      "code_info": "UDI-DI: 20650862161001;  All lots manufactured 3 years prior to correction initiation:  Lot Numbers: 453404 455900 458299 464069 455901 454344     448618 449703 449992 449993 450923 450924 451439 452012 452013 452575 453404 453472 454260 454344 454345 454589 454803 454850 454851 455359 455360 455370 455898 455900 455901 456447 456448 456904 456905 458298 458299 458300 458301 458642 458643 458644 458645 461545 463439 463441 463442 463443 463469 463586 463587 464069 464103 464104 464105 464669 464809 465368"
    }
  ]
}