{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianola",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72817",
      "recalling_firm": "Bayer Healthcare",
      "address_1": "1 Bayer Dr",
      "address_2": "N/A",
      "postal_code": "15051-9702",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.",
      "recall_number": "Z-0627-2016",
      "product_description": "Medrad Source Administration Sets, Catalog number INT CSS.  For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.",
      "product_quantity": "198,598",
      "reason_for_recall": "The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of  specification and may result in the system failing to position the dose correctly  during extraction, potentially leading to a low measurement of the extracted dose or  to a higher dose being extracted. The occluded SAS tubing may impair the priming  function and prompt an \u001cRP prime fail",
      "recall_initiation_date": "20151130",
      "center_classification_date": "20160111",
      "termination_date": "20161118",
      "report_date": "20160120",
      "code_info": "50856405, 50857510, 50860994,  50866789, 50867921, 50869464, 50869465, 50871131, 50872965,  50878229, 50878230, 50878231, 50878232, 50881328, 50881393,  50881394, 50881395, 50881506, 50881511, 50881512, 50882753,  50886316, 50886467, 50886468, 50886469, 50888285, 50888286,  50888287, 50888288, 50888373, 50890483, 50890484, 50890485,  50892357, 50892358, 50892359, 50892360, 60000321, 60000322,  60000323, 60000692, 60000789, 60000790, 60000833, 60000834,  60000835"
    }
  ]
}