{
  "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": "Ongoing",
      "city": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86426",
      "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 - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of  Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.",
      "recall_number": "Z-0704-2021",
      "product_description": "3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30\" (76 cm)  Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31\" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger, REF: CH3011-C; 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, Bag Hanger, REF: CH3020; 14 IN (36 cm) App 4.8 ml, Bifuse Add-On Set, Spiros w/Red Cap, Bag Spike, REF: CH3033; 5\" (13 cm) Bag Spike Adapter w/Spiros w/Red Cap, Vented Cap, REF: CH3034; 30\" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Hanger, REF: CH3128; Oncology Kit w/60\" (152 cm) Appx 2.3 ml, Smallbore Ext Set w/Spiros, Anti-Siphon Valve, ChemoClave, Clamp, Rotating Luer, Double ChemoClave Syringe Transfer Set, Spiros w/Red Cap, REF: CH3606; 5\" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps, REF: CH3625; 86\" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, REF: CH3642; Oncology Kit w/40\" (102 cm) Appx 4.7 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, Double ChemoClave Syringe Transfer Set, REF: CH3677; 5.5\" (14 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 ChemoClave, Spiros w/Red Cap, 3 Clamps, REF: CH3700; 50 IN (127 cm) Appx 6.4 ml, Ext Set w/ChemoClave, Spiros w/Red Cap, Clamp, REF: CH3703; 16 IN (41 cm) Appx 1.6 ml, Ext Set, ChemoClave, Spiros w/Red Cap, REF: CH3715; Oncology Kit, Ext w/Spiros, Grad Conn, 2 Vial Spikes w/Clave, Spinning Spiros , REF: CH3929; Oncology Kit, w/Ext, MicroClave, Clave, Grad Conn, Transfer, Spiros, Vial Spike, Clave, REF: CH3932; Oncology Kit, 12 IN Ext, Spiros, Graduated Adapter, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3943; Oncology Kit w/12\" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter, ChemoClave Vented Vial Spike, 20mm, ChemoClave Vented Vial Spike, 13mm, REF: CH3944; Oncology Kit, 16 IN (41 cm) Ext Set, ChemoClave, Graduated Conn, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3946; Oncology Kit, 21\" (53 cm) Appx 3.2 ml, Ext Set w/Spiros w/Red Cap, Graduated Adapter, Locking Universal Vented Vial Spike w/ChemoClave, Closed Vial Spike, 13mm w/ChemoClave, Spinning Spiros w/Red Cap, REF: CH3949; 46\" (117 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, REF: CH4002",
      "product_quantity": "534764",
      "reason_for_recall": "Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.",
      "recall_initiation_date": "20200831",
      "center_classification_date": "20201223",
      "report_date": "20201230",
      "code_info": "Lots:   4553702,  4605473,  4763191,  4775520,  4849205,  4549847,  4548779,  4572314,  4734247,  4763917,  4849208,  4741169,  4763921,  4560231,  4750962,  4549850,  4763200,  4734249,  4794307,  4806855,  4849220,  4861176,  4877472,  4605484,  4749780,  4795448,  4876942,  4719395,  4737146,  4764825,  4800210,  4866411,  4800214,  4734262,  4794308,  4795454,  4806862,  4849239,  4849248,  4849251,  4605504,  4719410,  4734273,  4757665,  4763982,  4799740,  4861174,  4605074,  4741282,  4751117,  4809117,  4877145,  4894538,  4557534,  4733509,  4741291,  4743763,  4774120,  4733512,  4865834,  4894550,  4573105,  4803126,  4808046,  4860027,  4806400,  4720476,  4724725,  4749443,  4786358,  4802674,  4849131,  4783296,  4730109,  4742662,  4759699,  4768019,  4794497,  4877852,  4897107,  4712378,  4749445,  4799839,  4806855,  4861176,  4719395,  4800210,  4764826,  4800214,  4719927,  4726732,  4733428,  4734262,  4741183,  4756802,  4763958,  4794308,  4794310,  4795452,  4806862,  4849230,  4849233,  4849239,  4719410,  4799839,  4859282"
    }
  ]
}