{
  "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": "217406",
      "product_res_number": "Z-0965-2026",
      "event_date_initiated": "2025-11-24",
      "event_date_posted": "2025-12-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98000",
      "product_code": "PHC",
      "k_numbers": [
        "K242117"
      ],
      "product_description": "LifeShield Drug Library Management (DLM);\nLifeShield Infusion Safety Software Suite v2.2\n\nList Number 17003-02",
      "code_info": "version 2.2.1\n\nUDI-DI 00887709127227\n\n\nIssue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.",
      "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": "For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.",
      "root_cause_description": "Software Design Change",
      "action": "Firm began notifying customers on 11/24/2025 via Urgent Medical Device Correction letters.  Customers were instructed to ensure all users or potential users of LifeShield ISSS DLM 2.2.1 with Plum Duo 1.1 drug libraries are made aware of the issue and the following proposed mitigations:\n\nUntil a software update is released, when performing the first Plum Duo v1.1 drug library review after the migration, the pharmacist is able to review the changes using alternate review mechanisms, as noted in the LifeShield Drug Library Management User Manual:\na) Accessing the version history view of the drug library\nb) Review drug library reports in CSV or HTML format\nc) Assess each change within LifeShield DLM to verify the accuracy of the changes (i.e., view impacted medication ruleset hard dose rate limit or view a CCA to verify a maximum rate setting)\n\nThe firm is developing a software update to correct the issue and will notify customers of the timing of the software update.",
      "product_quantity": "7 customers",
      "distribution_pattern": "US Nationwide distribution in the states of CA, IA, LA, 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"
      }
    }
  ]
}