{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48388",
      "product_res_number": "Z-0444-2007",
      "event_date_initiated": "2006-08-31",
      "event_date_posted": "2007-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-03-05",
      "res_event_number": "36306",
      "product_code": "MNT",
      "k_numbers": [
        "K003075"
      ],
      "product_description": "Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD",
      "code_info": "All units are subject to this notice (all serial numbers).",
      "firm_fei_number": "2024500",
      "recalling_firm": "Puritan Bennett Corporation",
      "address_1": "5931 Priestly Dr Ste 100 5931 Priestly Dr",
      "address_2": "Ste 100",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92008-8813",
      "reason_for_recall": "Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.",
      "root_cause_description": "Other",
      "action": "Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.",
      "product_quantity": "7,754 (in US)",
      "distribution_pattern": "Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.",
      "openfda": {
        "k_number": [
          "K240779",
          "K060044",
          "K122715",
          "K974539",
          "K955324",
          "K003075",
          "K103167",
          "K973004",
          "K102985",
          "K170367",
          "K242931",
          "K951264",
          "K233643",
          "K252182",
          "K113640",
          "K082660",
          "K191624",
          "K213521",
          "K990574",
          "K090113",
          "K982454",
          "K053607",
          "K121623",
          "K230173",
          "K071702"
        ],
        "registration_number": [
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          "3004428458",
          "2518422",
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          "3038562397",
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          "9611451",
          "3006783791",
          "3000126629",
          "3011120183",
          "3001400310",
          "3018783526",
          "3002797442"
        ],
        "fei_number": [
          "1000115734",
          "3004604967",
          "3002808128",
          "3020283264",
          "3004428458",
          "2518422",
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          "3010817335",
          "3033526676",
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          "3013190994",
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          "3002806988",
          "3000126629",
          "3011120183",
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          "3018783526",
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        ],
        "device_name": "Sv70 Ventilator",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5895",
        "device_class": "2"
      }
    }
  ]
}