{
  "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-0701-2021",
      "product_description": "5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75\" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40\" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14\" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros  w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114\" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml,  Add-On Set w/Spiros, Clave Spike, Clamp, Cap, REF: CH3290; 27\" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger, REF: CH3294; Secondary IV Oncology Kit, REF: CH3322; 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp, REF: CH3327; 40\" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers, REF: CH3373; Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port, REF: CH3397; 45\" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps, REF: CH3403; Oncology Kit w/20\" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave, REF: CH3507; Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap, REF: CH3546; 22\" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap, REF: CH3554; 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap, REF: CH3559; Oncology Kit w/Spinning Spiros, C-Clip, Red Cap, REF: CH3581; 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros, REF: CH3582; Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap, REF: CH3589; 77\" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: CH3639; 22\" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps, REF: CH3770; 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, REF: CH3771; 47\" (119 cm) 50 ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros, REF: CH4001; 47\" (119 cm) 50 ml Diluent Set For Channel 2 w/Bag Spike w/MicroClave Additive Port, Spiros, REF: CH4009; 30\" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: Z7100; 30\" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros, REF: CH4006; 60 IN(152cm)APPX 0.45ml,SMALLBORE EXT,MicroCLAVE,Spiros, REF: Z7040; 6\" (15 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 MicroClave, 3 Clamps, Spiros, REF: Z7151",
      "product_quantity": "55000",
      "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:   4726847  4764618  4749803  4882578  4719415  4858408  4763254  4799746  4909239  4763263  4807851  4849307  4711357  4734298  4784307  4877040  4603746  4751052  4809068  4719780  4887803  4902877  4741245  4773197  4793534  4853586  4603189  4749895  4800302  4749463  4751098  4775532  4853625  4877133  4902884  4726180  4751919  4763325  4742008  4763328  4877406  4902270  4589996  4741273  4751930  4764078  4849398  4894536  4742017  4784331  4894544  4774127  4719576  4787217  4908406  4752847  4866868  4908415  4854840  4853711  4894570  4759148  4605923  4784875  4800246  4807647  4866700  4590960  4802679  4889077"
    }
  ]
}