{
  "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": "203285",
      "product_res_number": "Z-0093-2024",
      "event_date_initiated": "2023-09-06",
      "event_date_posted": "2023-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "93016",
      "product_code": "BRY",
      "product_description": "BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01",
      "code_info": "REF: 1116-00, UDI-DI: 10885403512605.\n\nSoftware Versions: 1.7.3 and 1.7.4 (Limited commercial release)",
      "firm_fei_number": "2016493",
      "recalling_firm": "CareFusion 303, Inc.",
      "address_1": "10020 Pacific Mesa Blvd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4386",
      "additional_info_contact": "888-876-7128",
      "reason_for_recall": "When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value  NO , which could result in diversion of controlled substances from the automated dispensing cabinet.",
      "root_cause_description": "Software change control",
      "action": "On 9/6/23, correction notices were mailed to customers informing them to do the following:\n\n1) Do not use the global edit feature until your software is updated.\n2) If a global edit has already been performed, it is recommended to verify that the formulary device settings are accurate for the 4 configuration settings. Controlled substances that have been edited via the global edit feature should be reviewed retrospectively for discrepancies in the destruction bin and a manual witness record may be needed until the settings are adjusted for both \"Access Destruction Bin\" and \"Add to Destruction Bin (count/empty).\"\n3) Disseminate this notification within your facility network to ensure they are aware of this issue.\n4) Complete the attached Customer Response Form and return via email to bdrc44@bd.com\n\nSoftware patch for v.1.7.3 was released on July 20, 2023, and commercial release software v.1.7.4 was released for on July 31, 2023.  Firm will contact customers after the receipt of completed response forms to schedule times to install software update.\n\nThe following contacts were provided: Technical Support, 1-800-727-6102, 24 hours, 7 days a week; Customer Self Service Portal, https://service.carefusion.com; North American Regional Complaint Center, 1-844-823-5433, Say \"Recall\" when prompted, Mon-Fri 8:00am and 5:00pm CT, email: productcomplaints@bd.com",
      "product_quantity": "61",
      "distribution_pattern": "US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.",
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        "device_name": "Cabinet, Table And Tray, Anesthesia",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.6100",
        "device_class": "1",
        "k_number": [
          "K821307",
          "K871564",
          "K901474",
          "K921710",
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        ]
      }
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}