{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210236",
      "product_res_number": "Z-0224-2025",
      "event_date_initiated": "2023-03-13",
      "event_date_posted": "2024-10-24",
      "recall_status": "Completed",
      "res_event_number": "95428",
      "product_code": "DTQ",
      "k_numbers": [
        "K173834"
      ],
      "product_description": "Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00",
      "code_info": "UDI/DI 05060434420770:  Serial Numbers:  a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, AU6004578, AU6004579, AU6004580, AU6004587, AU6004588, AU6004590, AU6004591, AU6004603, AU6004604, AU6004605, AU6004606, AU6004607, AU6004609, AU6004610, AU6004613, AU6004731, AU6004771, AU6004773, AU6004776, AU6004777, AU6004778, AU6004779, AU6004781, AU6004782, AU6004919, AU6004920, AU6004921, AU6004922, AU6004923, AU6004924, AU6004925, AU6004926, AU6004927, AU6004929, AU6004930, AU6004955, AU6004957, AU6004958, AU6004960, AU6004963, AU6004966, AU6004968, AU6004970, AU6004971, AU6004972, AU6005010, AU6005021, AU6005022, AU6005023, AU6005024, AU6005025, AU6005026, AU6005027, AU6005028, AU6005029, AU6005030, AU6005037, AU6005038, AU6005039, AU6005040, AU6005041, AU6005042, AU6005057, AU6005065, AU6005109, AU6005110, AU6005118, AU6005124, AU6005125, AU6005355, AU6006351; \n\nSerial Numbers:  b) AU8001273, AU8001275, AU8001346, AU8001347, AU8001348, AU8001359, AU8001360, AU8001366, AU8001403, AU8001406, AU8001407, AU8001446, AU8001447, AU8001449",
      "firm_fei_number": "3006073153",
      "recalling_firm": "Spectrum Medical Ltd.",
      "address_1": "Harrier 4, Meteor Business Park 4 Meteor Business Park Cheltenham Road East",
      "city": "Gloucester",
      "country": "United Kingdom",
      "reason_for_recall": "The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.",
      "root_cause_description": "Component design/selection",
      "action": "All potentially affected product was identified.  The firm corrected all products between 03/13/2024 and 08/07/2024 during service visits.",
      "product_quantity": "172 units",
      "distribution_pattern": "US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.",
      "openfda": {
        "k_number": [
          "K842138",
          "K011088",
          "K052555",
          "K813034",
          "K863960",
          "K090006",
          "K822068",
          "K133598",
          "K021694",
          "K210130",
          "K861388",
          "K002116",
          "K071318",
          "K173834",
          "K943803",
          "K871131",
          "K221373",
          "K862973",
          "K851615",
          "K080832",
          "K870976",
          "K801097",
          "K915183",
          "K151349",
          "K060053",
          "K092463",
          "K190282",
          "K030141",
          "K070213",
          "K091007",
          "K020571",
          "K163531",
          "K772001",
          "K062396",
          "K103762",
          "K002118",
          "K863541",
          "K982014",
          "K102726",
          "K022947",
          "K942582",
          "K770002",
          "K232291",
          "K153376",
          "K221895",
          "K964017",
          "K202125",
          "K950990",
          "K172220",
          "K131041",
          "K851614",
          "K093882"
        ],
        "registration_number": [
          "2916596",
          "9680841",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "2184009",
          "1218444",
          "8010762",
          "9611109",
          "3019807891",
          "3006073153",
          "3002807090",
          "3010703925",
          "3009507273",
          "3005941719",
          "3011554160",
          "3001589655"
        ],
        "fei_number": [
          "2916596",
          "1000116158",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "1218444",
          "3002808267",
          "3019807891",
          "3006073153",
          "3010703925",
          "3009649876",
          "3006003617",
          "3002807111",
          "3009507273",
          "3011554160",
          "3001589655",
          "3005426550"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}