{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194359",
      "product_res_number": "Z-1365-2022",
      "event_date_initiated": "2022-05-20",
      "event_date_created": "2022-07-12",
      "recall_status": "Open, Classified",
      "res_event_number": "90423",
      "product_code": "FPL",
      "k_numbers": [
        "K141565"
      ],
      "product_description": "Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system",
      "code_info": "Model, country, and serial number:  MS20508: El Salvador DSPN-0003  Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001  MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002",
      "firm_fei_number": "2510954",
      "recalling_firm": "Draeger Medical Systems, Inc.",
      "address_1": "3135 Quarry Rd",
      "city": "Telford",
      "state": "PA",
      "postal_code": "18969-1042",
      "additional_info_contact": "Mike Kelhart\n215-660-2349",
      "reason_for_recall": "The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On May 20, 2022, the firm began to send Important Field Safety Notice letters to affected customers. Customers were instructed to avoid using the ventilator portion of the system due to the potential for enriched ambient air rising beyond safe levels until a replacement part can be installed and tested.\n\nThe firm will send customers a replacement kit and testing which will be completed at no charge to the customer. Draeger Service Representatives will call customers and schedule a service visit to update affected systems.",
      "product_quantity": "38 OUS (no US distribution)",
      "distribution_pattern": "No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.",
      "openfda": {
        "k_number": [
          "K123937",
          "K001019",
          "K790551",
          "K893624",
          "K161918",
          "K081399",
          "K220742",
          "K850496",
          "K103523",
          "K103524",
          "K062052",
          "K033565",
          "K031096",
          "K103527",
          "K061071",
          "K780964",
          "K831028",
          "K141565",
          "K941106",
          "K931346",
          "K932417",
          "K854065",
          "K022876",
          "K790689",
          "K103525"
        ],
        "device_name": "Incubator, Neonatal Transport",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5410",
        "device_class": "2",
        "registration_number": [
          "1054713",
          "1066270",
          "3005652389",
          "3009514037",
          "1625392",
          "8021995",
          "2510954",
          "3005934741",
          "3006891627",
          "3012348048",
          "3013923269"
        ],
        "fei_number": [
          "3009514037",
          "2510954",
          "3005934741",
          "1000114111",
          "3000957797",
          "3006891627",
          "1000058335",
          "3004846435",
          "3012348048",
          "3006363476",
          "3013923269"
        ]
      }
    }
  ]
}