{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78418",
      "recalling_firm": "ICU Medical Inc",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and  Philippines",
      "recall_number": "Z-0195-2018",
      "product_description": "ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:  (a) 16037-64-01; MedNet 6.1  b) 16037-64-02; MedNet 6.1  c) 16037-64-03; MedNet 6.1  d) 16037-64-04; MedNet 6.21      The ICU Medical MedNet  Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.",
      "product_quantity": "108 installations",
      "reason_for_recall": "Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when:  1.\tMedication entries are built with the same displayed name and diluent amount AND;  2.\tThe piggyback or interruptible settings differ from one CCA to another AND;  3.\tThe drug library is exported then imported into the MedNet Meds program.    The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered.  Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when:  1.\tThe Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND;  2.\tThe medication entry built as the Full rule set has a blank medication amount with the medication units in  mg  AND;  3.\tBoth medication entries have different piggyback options set AND;  4.\tThe drug library is exported then imported into the MedNet Meds program.    In this case, the piggyback options will be changed during an import of such drug library.",
      "recall_initiation_date": "20171030",
      "center_classification_date": "20171206",
      "termination_date": "20200903",
      "report_date": "20171213",
      "code_info": "All MedNet 6.1 and 6.21 installations",
      "more_code_info": ""
    }
  ]
}