{
  "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": [
    {
      "status": "Terminated",
      "city": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86054",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "N/A",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.",
      "recall_number": "Z-0261-2021",
      "product_description": "NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case.  UDI:(01)10887709058757(17)250101(30)100(10)4573278;  (01)10887709058757(17)250101(30)100(10)4590919;  (01)10887709058757(17)250201(30)100(10)4712217;  (01)10887709058757(17)241201(30)100(10)4537440;  (01)10887709058757(17)241201(30)100(10)4549906;  (01)10887709058757(17)250101(30)100(10)4559515;  (01)10887709058757(17)250201(30)100(10)4719743;  (01)10887709058757(17)250201(30)100(10)4726897;  (01)10887709058757(17)250201(30)100(10)4735597;  (01)10887709058757(17)241101(30)100(10)4461205.     CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. .",
      "product_quantity": "Total of all products (Listed #1 thru 101) = 304735 units",
      "reason_for_recall": "Identification of a  potential  manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.",
      "recall_initiation_date": "20200706",
      "center_classification_date": "20201022",
      "termination_date": "20230511",
      "report_date": "20201028",
      "code_info": "Lot Numbers:4573278, 4590919, 4712217, 4537440, 4549906, 4559515,4719743, 4726897, 4735597, 4461205."
    }
  ]
}