{
  "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": "2026-03-18",
    "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": "90606",
      "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 distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, Canada.",
      "recall_number": "Z-1682-2022",
      "product_description": "Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S;  ChemoLock Bag Spike/CL-10;  ChemoLock w/Mini Bag Spike/CL-17;  8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950;  31\" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951;  7.5\" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967;  6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118;  ChemoLock Kit w/ 5\" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158;  ChemosafeLock Bag Spike/KL-BS001U3;  ChemosafeLock Vial Adapter/KL-VA201U3;  ChemosafeLock Vial Adapter/KL-VA202U3;  ChemosafeLock Vial Adapter/KL-VA321U3;  ChemosafeLock Vial Adapter/KL-VA322U3;  ChemoLock Vented Vial Spike/011-CL-51;  Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155;  Puerto ChemoLock/034-CL2100;  ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70;  ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72",
      "product_quantity": "358,975",
      "reason_for_recall": "Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.",
      "recall_initiation_date": "20220627",
      "center_classification_date": "20220907",
      "report_date": "20220914",
      "code_info": "OUS Distributed Only Item/Lots: 011-CL-80S/5843950; CL-10/5850516; CL-17/5816314, 5829878, 5842209, 5850503; CL3950/5845117, 5885020; CL3951/5842199, 5872831; CL3967/5829901, 5842210; CL4118/5825274, 5872840; KL-BS001U3/5851020, 5851021, 5851022, 5910255, 5910258; KL-VA201U3/5819364; KL-VA202U3/5819370, 5910262; KL-VA321U3/5915973; KL-VA322U3/5920744; 011-CL-51/5850505; 011-CL4155/5816324; 034-CL2100/5842230; 034-CL-70/5816321; 034-CL-72/5816344"
    }
  ]
}