{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Clemente",
      "address_1": "951 Calle Amanecer",
      "reason_for_recall": "Potential for leakage due to defect in the thermoset check valve component.",
      "address_2": "",
      "product_quantity": "27,250 units total",
      "code_info": "Item number:41412-01.  Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611).  Expiration Date 01/01/2021.",
      "center_classification_date": "20181222",
      "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",
      "state": "CA",
      "product_description": "Thermoset Room Temperature Closed Loop Injectate Delivery System.  1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090",
      "report_date": "20190102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "ICU Medical, Inc.",
      "recall_number": "Z-0661-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81210",
      "termination_date": "20210325",
      "more_code_info": "",
      "recall_initiation_date": "20181005",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}