{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Totowa",
      "address_1": "20 Campus Rd",
      "reason_for_recall": "The EnFlow Warmer Strap  does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may  have contact with skin for less than 24 hours.",
      "address_2": "",
      "product_quantity": "11803 cases",
      "code_info": "a) 510(k): K060537  b) Medical device listing number: D071942    All enFlow Warmer Straps in the field present a potential for tissue injury.  Sold separately as Product #: 980304 and 980304EU  Included as an accessory in following enFlow products:    Military      Domestic  91000153 980100  91000154 980100EU  91000156 980105VS  91000103",
      "center_classification_date": "20120709",
      "distribution_pattern": "Nationwide Distribution.",
      "state": "NJ",
      "product_description": "enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL  100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY,  MODEL 120).    The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.",
      "report_date": "20120718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Vital Signs Devices, a GE Healthcare Company",
      "recall_number": "Z-1972-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62441",
      "termination_date": "20130819",
      "more_code_info": "",
      "recall_initiation_date": "20120220",
      "postal_code": "07512-1210",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}