{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91392",
      "recalling_firm": "Smiths Medical ASD Inc.",
      "address_1": "6000 Nathan Ln N",
      "address_2": "N/A",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN",
      "recall_number": "Z-0965-2023",
      "product_description": "CADD Administration Set, List Numbers:  a) REF 21-7600-24,  b) REF 21-7609-24,  c) REF 21-7624-24,  d) REF 21-7649-24,  e) REF 21-7600-24JP,  f) REF 21-7609-24JP,  g) REF 21-7624-24JP,  h) REF 21-7649-24JP   Computerized Ambulatory Delivery Device",
      "product_quantity": "214668 units",
      "reason_for_recall": "There are two potential issues with CADD Infusion  System Infusion Sets:  (1) Lack of Delivery or  Underdelivery related to Tubing Occlusion and (2) False \"No Disposable Attached (NDA)\" Alarms",
      "recall_initiation_date": "20221209",
      "center_classification_date": "20230130",
      "report_date": "20230208",
      "code_info": "a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers:  4084914 through 4329633;   b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers:  4072200 through 4334090;  c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers:  4092506 through 4309481;  d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers:  4076410 through 4334357;  e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers:  4084914 through 4329633,  f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers:  4072200 through 4334090;  g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers:  4092506 through 4309481;  h) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers:  4076410 through 4334357."
    }
  ]
}