{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217444",
      "product_res_number": "Z-0966-2026",
      "event_date_initiated": "2025-11-24",
      "event_date_posted": "2025-12-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98022",
      "product_code": "PHC",
      "k_numbers": [
        "K242117"
      ],
      "product_description": "LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2\n\nProduct No. 17003-02",
      "code_info": "LifeShield Infusion Safety Software Suite v2.2\n\nUDI-DI 00887709127227",
      "firm_fei_number": "3013319212",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "600 N Field Dr",
      "city": "Lake Forest",
      "state": "IL",
      "postal_code": "60045-4835",
      "additional_info_contact": "Technical Support\n800-241-4002 Ext. 3",
      "reason_for_recall": "Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.",
      "root_cause_description": "Software Design Change",
      "action": "On November 24, 2025, the firm notified customers via Urgent Medical Device Correction letters. Consignees were asked to take the following actions:\n\n1. Ensure all users or potential users of LifeShield DLM 2.2.1 are immediately made aware of this notification\nand proposed mitigations.\n2. Until a software update is released, limit any newly created or edited Concentration Limits to one decimal\nplace of precision for limits less than 100.\n\nICU Medical is developing a software update to correct this issue and will notify customers of the timing of the software update.",
      "product_quantity": "12 customers",
      "distribution_pattern": "US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.",
      "openfda": {
        "k_number": [
          "K242117",
          "K141474",
          "K252130",
          "K182092",
          "K223606",
          "K243062",
          "K211124",
          "K141193",
          "K210075",
          "K230665"
        ],
        "registration_number": [
          "3015158050",
          "3013319212",
          "1643817",
          "3007738736",
          "1018233",
          "1423507",
          "3000240707",
          "9617594",
          "3015437214",
          "3005778453",
          "2024064",
          "3024706751",
          "3014732157",
          "9612051",
          "1416980",
          "3004906872",
          "9615050",
          "3003879246",
          "3010972758",
          "1047843",
          "1314492",
          "3012337868",
          "3004548776",
          "3005210579",
          "1319660",
          "2016493"
        ],
        "fei_number": [
          "3015158050",
          "3013319212",
          "1643817",
          "3007738736",
          "3002999813",
          "1018233",
          "3000240707",
          "3015437214",
          "3005778453",
          "2024064",
          "3024706751",
          "3014732157",
          "1416980",
          "3004906872",
          "3002806457",
          "3003879246",
          "3010972758",
          "1047843",
          "3003807466",
          "1000136478",
          "1314492",
          "3012337868",
          "3004548776",
          "3005210579",
          "3008002452",
          "2016493"
        ],
        "device_name": "Infusion Safety Management Software",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}