{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96069",
      "recalling_firm": "CareFusion 303, Inc.",
      "address_1": "10020 Pacific Mesa Blvd",
      "address_2": "N/A",
      "postal_code": "92121-4386",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba  O.U.S.: Canada",
      "recall_number": "Z-1231-2025",
      "product_description": "BD Alaris Pump Module REF 8100    The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration",
      "product_quantity": "242,098 systems",
      "reason_for_recall": "Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set.  This issue potentially could result in an accidental over infusion if the roller clamp is left open.",
      "recall_initiation_date": "20250123",
      "center_classification_date": "20250224",
      "report_date": "20250305",
      "code_info": "Catalog Number: 8100 UDI-DI codes: 10885403810046 10885403517723 Software Version: 12.1.2 Serial/Lot Numbers:  Pending"
    }
  ]
}