{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "214420",
      "product_res_number": "Z-2095-2025",
      "event_date_initiated": "2025-06-20",
      "event_date_posted": "2025-07-17",
      "recall_status": "Open, Classified",
      "res_event_number": "97072",
      "product_code": "PHC",
      "k_numbers": [
        "K133801"
      ],
      "product_description": "Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX",
      "code_info": "UDI-DI: 00085412091570;\nSerial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "Certain Spectrum infusion pumps may have an incorrect version of software.",
      "root_cause_description": "Employee error",
      "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 6/20/25 was sent to customers.\n\nActions to be Taken by Customers\n1. Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump.\n2. Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured on the next page.\nAdditionally, the software version is indicated in the pump menu which can be accessed by following the steps.\n For V6: From the Pump Information screen, press the  sw info  soft key to display the software version screen.\n For V8: From the Select Care Area screen, press the  options menu  soft key. Select  User Options  and press OK. Select  View Information  and press OK. Select  Pump Information  and press OK to display the Pump Info screen.\n3. Contact Baxter to confirm the software version on the affected pumps and to schedule service if required. Baxter Global Technical Services can be reached at 800-843-7867 (select option 1, then option 2), Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.\n4. If you received this communication directly from Baxter, acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.\n5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them",
      "product_quantity": "14 units",
      "distribution_pattern": "US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.",
      "openfda": {
        "k_number": [
          "K141193",
          "K230665",
          "K223606",
          "K182092",
          "K252130",
          "K211124",
          "K243062",
          "K242117",
          "K210075",
          "K141474"
        ],
        "registration_number": [
          "2016493",
          "1314492",
          "1319660",
          "1423507",
          "3015158050",
          "3000240707",
          "9615050",
          "1416980",
          "3013319212",
          "9612051",
          "3012337868",
          "3015437214",
          "9617594",
          "1018233",
          "1047843",
          "2024064",
          "3024706751",
          "3005778453",
          "3003879246",
          "3007738736",
          "3004548776",
          "3014732157",
          "1643817",
          "3004906872"
        ],
        "fei_number": [
          "2016493",
          "1314492",
          "3002806457",
          "3015158050",
          "3000240707",
          "3008002452",
          "3003807466",
          "1416980",
          "3013319212",
          "3002999813",
          "3012337868",
          "3015437214",
          "1000136478",
          "1018233",
          "1047843",
          "2024064",
          "3024706751",
          "3005778453",
          "3003879246",
          "3007738736",
          "3004548776",
          "3014732157",
          "1643817",
          "3004906872"
        ],
        "device_name": "Infusion Safety Management Software",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}