{
  "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": "204054",
      "product_res_number": "Z-0438-2024",
      "event_date_initiated": "2023-10-19",
      "event_date_posted": "2023-12-01",
      "recall_status": "Open, Classified",
      "res_event_number": "93347",
      "product_code": "DWC",
      "k_numbers": [
        "K102147"
      ],
      "product_description": "CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A",
      "code_info": "UDI: (01)00860000846110/Serial Numbers: 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, 11160320, 11161109, 11161832, 11161836, 11161837, 11161838, 11161839, 11160216, 11160217, 11160218, 11160548, 11160549, 11160550, 11160103, 11160338, 11160339, 11160364, 11160365, 11160366, 11161117, 11161118, 11161827,11161828, 11161829, 11161942, 11161943, 11161944, 11161978, 11162016, 11162018, 11160461, 11160462, 11160463, 11160464, 11160465, 11160579, 11161487, 11161488, 11161489, 11161613, 11161692, 11161695, 11161701, 11161702, 11161696\n11161627, 11162262, 11160298, 11160378, 11160380, 11160385, 11160386, 11160387, 11160388, 11160377, 11160379, 11160376, 11160439, 11160440, 11161458, 11161460, 11161815, 11161816, 11161817, 11161818, 11161819, 11161907, 11161916, 11162057, 11162078, 11162079, 11162080, 11160375, 11160083, 11160270, 11160271, 11161018, 11161024, 11161019, 11161023, 11161022, 11161020, 11161021, 11160553, 11160554, 11161143, 11161144, 11161147, 11162002, 11162008, 11162009, 11162010, 11162011, 11160277, 11160290, 11160391, 11160289, 11161667, 11161668, 11161669, 11161670, 11161972, 11161973, 11161294, 11162139, 11162141, 11162142, 11162143, 11162170, 11162171  11160031, 11161076, 11161077, 11161890, 11162128, 11162129, 11161187, 11161189, 11161193, 11161194, 11161545, 11161546, 11161547, 11161549, 11160024, 11160025, 11160027, 11160075, 11161126, 11160314, 11162053, 11162054\n11160071\n11161083, 11161084, 11161085, 11161086, 11161087, 11161088, 11161089, 11161090, 11161091, 11161092",
      "firm_fei_number": "3007899424",
      "recalling_firm": "CardioQuip, LLC",
      "address_1": "8422 Calibration Ct",
      "city": "College Station",
      "state": "TX",
      "postal_code": "77845-5328",
      "additional_info_contact": "CardioQuip Customer Service\n888-267-6700",
      "reason_for_recall": "There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.",
      "root_cause_description": "Device Design",
      "action": "On 10/19/23, CardioQuip issued a \"Urgent: Medical Device Correction\" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication.  CardioQuip ask consignees to take the following actions: \n\n1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use.\n2.Never operate the device dry (see communication for further details).\n3. Design Changes to be implemented (see communication for further details).\nA. Relocation of the water Level Sensor (see communication for further details).\nB. Software Update (see communication for further details).\n4. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. \n5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm",
      "product_quantity": "150 units",
      "distribution_pattern": "US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA",
      "openfda": {
        "k_number": [
          "K191402",
          "K896974",
          "K896971",
          "K896975",
          "K071521",
          "K003145",
          "K014016",
          "K883603",
          "K220635",
          "K945720",
          "K873813",
          "K841402",
          "K896972",
          "K130300",
          "K140012",
          "K873924",
          "K896973",
          "K896393",
          "K001520",
          "K212657",
          "K874927",
          "K031544",
          "K822874",
          "K052601",
          "K831677",
          "K102147",
          "K873699",
          "K893940",
          "K810647",
          "K122813"
        ],
        "registration_number": [
          "1723241",
          "3001588119",
          "1828100",
          "1516825",
          "3007899424",
          "1928237",
          "3006073153",
          "1649914",
          "1720929",
          "9611109"
        ],
        "fei_number": [
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          "1516825",
          "3007899424",
          "1928237",
          "1000517719",
          "3002808267",
          "3006073153",
          "3001665800",
          "1720929"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}