{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "184072",
      "product_res_number": "Z-0452-2021",
      "event_date_initiated": "2020-09-22",
      "event_date_created": "2020-11-13",
      "recall_status": "Open, Classified",
      "res_event_number": "86575",
      "product_code": "LZH",
      "k_numbers": [
        "K153074"
      ],
      "product_description": "Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.",
      "code_info": "All lots of products manufactured in the below timespan:  July 1, 2015 and July 20, 2019",
      "firm_fei_number": "3014524790",
      "recalling_firm": "Cardinal Health 200, LLC",
      "address_1": "15 Hampshire St Bldg 5",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "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 Product Correction Notice dated 922/20 was sent to customers.\n\nCardinal Health had previously notified customers of a Medical Device Product Advisory in December 2019 due to the\npotential risk of leaks with Kangaroo enteral feeding spike sets*. The purpose of this communication is to inform you\nthat we have updated this notification to include all unexpired lots manufactured to date, in addition, we have added\ntwo additional product codes of Kangaroo Connect 500ml and 1000ml bag sets to the product correction notice. The\nProduct Correction Notice is for all unexpired lots of the below Kangaroo enteral feeding spike sets and all lots of\nKangaroo Connect 500ml and 1000ml bag sets manufactured between July 1, 2015 and July 20, 2019. We continue\nto receive complaints of leaking at the interface of the tube and spike connector, in addition to complaints of leaking\ndue to PVC tubing disconnecting from the cassette in Connect bag sets.\n\n1) INSPECT your inventory for affected product.\n2) COMMUNICATE with all personnel that utilize these feeding sets the risk of leaks at the\ninterface of the tube and spike connector in Kangaroo enteral feeding spike sets and the risk\nof PVC tubing disconnecting from the cassette in Kangaroo Connect Bag Sets causing\nleaking.\n3) INSPECT the feeding set for leaks after the pump has been primed, after the infusion has\nstarted, and throughout the infusion process.\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",
      "product_quantity": "314460",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K011868",
          "K913413",
          "K003047",
          "K954735",
          "K981541",
          "K221603",
          "K891575",
          "K200051",
          "K901458",
          "K951429",
          "K940555",
          "K141479",
          "K143263",
          "K923066",
          "K943733",
          "K946168",
          "K111381",
          "K011587",
          "K031199",
          "K940556",
          "K031407",
          "K131154",
          "K913958",
          "K232205",
          "K945964",
          "K873119",
          "K220230",
          "K253558",
          "K914216",
          "K040196",
          "K952671",
          "K153074",
          "K060316",
          "K040957"
        ],
        "registration_number": [
          "1419562",
          "9612030",
          "3009247326",
          "3004906872",
          "1423537",
          "3016705853",
          "9614277",
          "3012302888",
          "3005669815",
          "1722139",
          "3008717264",
          "3014656668",
          "9611018",
          "3007289408",
          "3013914978",
          "1417592",
          "3009211636",
          "3011200334",
          "9610849",
          "3008058400",
          "3046434077",
          "3013788631",
          "3031190571",
          "3012169247",
          "3002879653",
          "2029015",
          "3012421607",
          "3014637079",
          "3012337868",
          "3001124136",
          "2183673",
          "3037001242",
          "1416980",
          "3005674464",
          "9610825",
          "1921846",
          "3013764800",
          "2011171",
          "3000268902",
          "3005700264",
          "3012341425"
        ],
        "fei_number": [
          "1419562",
          "3002806934",
          "3009247326",
          "3004906872",
          "1000117172",
          "3016705853",
          "3012302888",
          "3005669815",
          "3008717264",
          "3014656668",
          "3007289408",
          "3013914978",
          "1417592",
          "3009211636",
          "3011200334",
          "3008058400",
          "3046434077",
          "3002808143",
          "3013788631",
          "3031190571",
          "3002806469",
          "3012169247",
          "3002879653",
          "1000160458",
          "3012421607",
          "3014637079",
          "3002807391",
          "3012337868",
          "3001124136",
          "2183673",
          "3001236905",
          "3037001242",
          "1416980",
          "3005674464",
          "3002692512",
          "1921846",
          "3013764800",
          "2011171",
          "3000268902",
          "3005700264",
          "3012341425"
        ],
        "device_name": "Pump, Infusion, Enteral",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}