{
  "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": "124685",
      "product_res_number": "Z-0607-2014",
      "event_date_initiated": "2013-11-08",
      "event_date_posted": "2013-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-03-23",
      "res_event_number": "66979",
      "product_code": "NEP",
      "product_description": "IntelliFill i.v. Pharmacy Compounding Device (PCD).\r\n\r\nIntended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.",
      "code_info": "Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520.",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n224-948-2000",
      "reason_for_recall": "Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "A Service Bulletin was sent to all IntelliFill i. v. customers February 22, 20 I 0 by USPS mail.\r\n\r\nThe Service Bulletin informs customers that IntelliFill i.v. operators are to be trained to listen for the running HEPA filtration fan motor and observe/feel for airflow coming from the automation deck.\r\n\r\nThe field service engineer dispatched to the site replaced the damaged sensor on 11-Feb-2010 and a Service Bulletin was sent to all customers regarding the function and use of the HEPA filter on 22-Feb-2010.\r\n\r\nA new HEPA sensor was designed and installed into all current IntelliFill i.v. devices between 21-July-2011 to 9-Feb-2012.",
      "product_quantity": "28 devices",
      "distribution_pattern": "Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.",
      "openfda": {
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          "3014132286",
          "1000632857",
          "3014579161",
          "3002807111",
          "3006153342",
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        ],
        "device_name": "System/Device, Pharmacy Compounding",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}