{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "178932",
      "product_res_number": "Z-2100-2020",
      "event_date_initiated": "2019-12-26",
      "event_date_created": "2020-05-22",
      "recall_status": "Open, Classified",
      "res_event_number": "84656",
      "product_code": "LZH",
      "k_numbers": [
        "K040196",
        "K141479",
        "K153074"
      ],
      "product_description": "Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100",
      "code_info": "All",
      "firm_fei_number": "3004008697",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "city": "Dublin",
      "state": "OH",
      "postal_code": "43017-1091",
      "reason_for_recall": "The feeding spike sets may leak at the interface of the tube and spike connector.",
      "root_cause_description": "Process control",
      "action": "A Medical Device Product Advisory letter dated 12/23/19 was sent to customers.\n\n1) INSPECT your inventory for affected product.\n2) COMMUNICATE with all personnel that utilize the equipment the risk of leaks at the interface\nof the tube and spike connector.\n3) INSPECT the feeding set for leaks after the pump has been primed and the infusion has\nstarted.\n\" If a leak is detected the feeding set must be discarded and a new feeding set must\nbe obtained. Inspect the new feeding set for leaks in the same manner.\n4) NOTIFY any customers to whom you may have distributed or forwarded affected product\nabout this product advisory.\n5) RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or\nemail to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected\nproduct.\n\nPlease contact the Customer Service group for any questions related to this action:\n\" Hospital800-964-5227\n\" Federal Government800-444-1166\n\" Distributor800-635-6021\n\" All other customers888-444-5440\nFor questions related to the notification and/or acknowledgement form that are not adequately\naddressed in this letter, please contact the market action team at:\nGMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.",
      "product_quantity": "114,731, 290 total units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K914216",
          "K913958",
          "K111381",
          "K952671",
          "K873119",
          "K003047",
          "K901458",
          "K031199",
          "K040196",
          "K946168",
          "K143263",
          "K940556",
          "K253558",
          "K011868",
          "K232205",
          "K200051",
          "K943733",
          "K131154",
          "K954735",
          "K940555",
          "K031407",
          "K923066",
          "K141479",
          "K220230",
          "K891575",
          "K153074",
          "K040957",
          "K951429",
          "K011587",
          "K913413",
          "K221603",
          "K945964",
          "K060316",
          "K981541"
        ],
        "registration_number": [
          "3005669815",
          "3012341425",
          "3046434077",
          "9610849",
          "9610825",
          "9611018",
          "3016705853",
          "3009247326",
          "3012169247",
          "3012337868",
          "3001124136",
          "3013914978",
          "3002879653",
          "9612030",
          "3037001242",
          "1416980",
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          "3031190571",
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          "3014637079",
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          "3012302888",
          "1419562",
          "2011171",
          "2029015",
          "3007289408",
          "1423537",
          "3000268902",
          "1417592",
          "3013764800",
          "3013788631",
          "3014656668",
          "3011200334"
        ],
        "fei_number": [
          "3005669815",
          "1000117172",
          "3012341425",
          "3046434077",
          "3002806469",
          "3016705853",
          "3009247326",
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          "3012337868",
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          "3013914978",
          "3002879653",
          "3037001242",
          "3002806934",
          "1416980",
          "3012421607",
          "3031190571",
          "2183673",
          "3002807391",
          "3005674464",
          "3009211636",
          "3008717264",
          "3004906872",
          "3002808143",
          "3014637079",
          "3005700264",
          "1000160458",
          "1921846",
          "3008058400",
          "3012302888",
          "1419562",
          "2011171",
          "3001236905",
          "3007289408",
          "3000268902",
          "1417592",
          "3013764800",
          "3013788631",
          "3014656668",
          "3011200334"
        ],
        "device_name": "Pump, Infusion, Enteral",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}