{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "66483",
      "product_res_number": "Z-0588-2008",
      "event_date_initiated": "2007-11-29",
      "event_date_posted": "2008-01-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-04-29",
      "res_event_number": "45919",
      "product_code": "MEB",
      "k_numbers": [
        "K062457"
      ],
      "product_description": "Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015",
      "code_info": "Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and  07K020",
      "firm_fei_number": "1416980",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "Rt. 120 & Wilson Rd",
      "city": "Round Lake",
      "state": "IL",
      "postal_code": "60073",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.",
      "root_cause_description": "Process control",
      "action": "Baxter on 11/30/07 sent an Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential leaks during filling or use of the infusor. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any  clinical/technical questions were directed to the Baxter Healthcare Product Information Center at 1-800-933-0303.",
      "product_quantity": "86,192 units",
      "distribution_pattern": "Worldwide: USA,  Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia and New Zealand.",
      "openfda": {
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        "device_name": "Pump, Infusion, Elastomeric",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}