{
  "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": "2026-08-22",
    "results": {
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      "cfres_id": "168809",
      "product_res_number": "Z-0663-2019",
      "event_date_initiated": "2018-10-05",
      "event_date_created": "2018-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-03-25",
      "res_event_number": "81210",
      "product_code": "KRB",
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      "product_description": "Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate.  1 unit per Cavity #2-4\"x9\" Cav/20 pieces per case R1-15645",
      "code_info": "Item number: 41424-03.  Lot number (UDI) Expiration Date: 3580033 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580033) 12/1/2020; 3580037 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580037) 12/1/2020; 3580038 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580038) 12/1/2020; 3585768 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585768) 12/1/2020; 3585769 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585769) 12/1/2020; 3585770 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585770) 12/1/2020; 3585771 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585771) 12/1/2020; 3585772 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585772) 12/1/2020; 3585773 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585773) 1/1/2021; 3585774 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585774) 1/1/2021;  3585775 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585775) 1/1/2021; 3598139 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598139) 1/1/2021; 3598143 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598143) 1/1/2021; 3610803 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3610803) 1/1/2021; 3642242 ((01) 0 0840619 04414 5 (17) 210301(30) 01 (10)3642242) 3/1/2021; 3656680 ((01) 0 0840619 04414 5 (17) 210401(30) 01 (10)3656680) 4/1/2021",
      "firm_fei_number": "2025816",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "city": "San Clemente",
      "state": "CA",
      "postal_code": "92673-6212",
      "additional_info_contact": "844-654-7780",
      "reason_for_recall": "Potential for leakage due to defect in the thermoset check valve component.",
      "root_cause_description": "Equipment maintenance",
      "action": "On October 5, 2018, ICU Medical URGENT MEDCAL DEVICE RECALL letters were sent to ICU Medical's consignees advising them of this matter. Each letter contained a response form and a return label.",
      "product_quantity": "25,640 units",
      "distribution_pattern": "United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO,  MS, MT, NJ, NY, NC, OH, OK,  OR, PA, SC, TN, TX, VA, WA, WI, WV, WY",
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        "device_name": "Probe, Thermodilution",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1915",
        "device_class": "2"
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