{
  "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": "2026-04-22",
    "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": "78191",
      "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": "US Distribution and Internationally to TH.",
      "recall_number": "Z-0106-2018",
      "product_description": "SURPLUG MICRO CONNECTOR Item No. 066-C3352;   111\" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167;   32\" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243;   10\" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084;   3-Way High Flow Stopcock w/Rotating Luer Item No. B4020;   38\" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054;   300\" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121;   3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154;   33\" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171;   35\" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181;   113\" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153;   131\" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. B9900-510;   101\" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock Item No. B99262;   140\" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0060;   140\" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0143;   40\" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer Item No. Z1746;   136\" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z2003;   137\" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext Item No. Z2367;   48\" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore Item No. Z2722;   126\" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext Item No. Z2760;   114\" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave Item No. Z3284;   3-Way Stopcock w/Rotating Luer Item No. Z3295;   111\" (282 cm) Appx 14.0 ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 3-Way Stopcock, Rotating Luer w/Filter Cap, 1 Ext Item No. Z3705       The ICU intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).",
      "product_quantity": "24,475 (17,225 in US)",
      "reason_for_recall": "ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.",
      "recall_initiation_date": "20170831",
      "center_classification_date": "20171117",
      "termination_date": "20181017",
      "report_date": "20171129",
      "code_info": "Lot Number 3458321, 3462452, 3465813, 3442569, 3446005, 3450752, 3465816, 3456237, 3486340, 3451451, 3447667, 3447427, 3471329, 3462010, 3447673, 3470589, 3466170, 3462856, 77-979-Y1, 76-113-Y1, 76-114-Y1, 77-981-Y1, 77-259-Y1, 77-023-HE, 77-481-Y1, 78-637-HE, 77-034-HE, 77-222-Y1, 77-341-HE, 77-354-Y1, 77-613-Y1, 77-033-HE, 76-101-Y1, 77-305-HE, 76-059-Y1, 77-149-Y1, 78-466-HE, 79-571-JW, 77-203-Y1"
    }
  ]
}