{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189239",
      "product_res_number": "Z-0043-2022",
      "event_date_initiated": "2021-08-06",
      "event_date_created": "2021-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-10-18",
      "res_event_number": "88671",
      "product_code": "NCX",
      "k_numbers": [
        "K153226"
      ],
      "product_description": "ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312",
      "code_info": "All Lots",
      "firm_fei_number": "3003793491",
      "recalling_firm": "ZOLL Circulation, Inc.",
      "address_1": "2000 Ringwood Ave",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95131-1728",
      "additional_info_contact": "Sam Nanavati\n408-419-2950",
      "reason_for_recall": "Labeling update concerning potential leaks from  the catheter or the start-up kit (SUK) tubing",
      "root_cause_description": "Labeling design",
      "action": "Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an \"Urgent Medical Device Recall (Correction)\" Notification to all affected US consignees via UPS.  In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: \n\n\n1.\tIf you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com.\n\n2\tProvide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.\n\n3\tMaintain a copy of the recall notification and attachment with the IFU for reference.  ZOLL will provide a method to obtain the updated IFU once it is released. \n\n4\tIf you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems  to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178).\n\n5\tSign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice.\n\n6.\tIf you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization.\n\nActions Underway by ZOLL:\n\n1.\tZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users.\n\n2.\tZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. \n\n3.\tZOLL is retraining all Sales staff to the revised IFU.\n\n\n4. If we could be of any further assi",
      "product_quantity": "5, 345 KIts",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.",
      "openfda": {
        "k_number": [
          "K153162",
          "K030421",
          "K051912",
          "K152946",
          "K012512",
          "K060308",
          "K070161",
          "K063829",
          "K022366",
          "K141139",
          "K080908",
          "K063405",
          "K101987",
          "K223746",
          "K033623",
          "K153226",
          "K213031",
          "K080899",
          "K071358",
          "K052443",
          "K081936",
          "K150046",
          "K072234",
          "K014241",
          "K071008",
          "K220008"
        ],
        "registration_number": [
          "2024311",
          "3010617000",
          "2029275",
          "3029871637"
        ],
        "fei_number": [
          "3003793491",
          "3029871637",
          "2024311",
          "1000306431"
        ],
        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
      }
    }
  ]
}