{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "66415",
      "product_res_number": "Z-0695-2008",
      "event_date_initiated": "2007-11-21",
      "event_date_posted": "2008-01-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-09-30",
      "res_event_number": "45889",
      "product_code": "CBT",
      "k_numbers": [
        "K902771"
      ],
      "product_description": "Smiths Medical,  Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016",
      "code_info": "Lot Numbers: 1189082, 1231444, 1178100, and 1225588.",
      "firm_fei_number": "1526863",
      "recalling_firm": "Smiths Medical Asd Inc",
      "address_1": "6250 Shier Rings Rd",
      "city": "Dublin",
      "state": "OH",
      "postal_code": "43016-1270",
      "additional_info_contact": "614-889-2220",
      "reason_for_recall": "Misbranded; The product codes are labeled incorrectly with a green promotional label for \"New split septum sampling site. Only use needle-free access devices .......\", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device",
      "root_cause_description": "Packaging process control",
      "action": "Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot.  Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.",
      "product_quantity": "1440 units",
      "distribution_pattern": "Nationwide including the states of  CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.",
      "openfda": {
        "k_number": [
          "K781857",
          "K944941",
          "K841486",
          "K831034",
          "K833582",
          "K822248",
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          "K940575",
          "K950098",
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          "K895171",
          "K945719",
          "K811860",
          "K931873",
          "K771013",
          "K912043",
          "K071269",
          "K872244",
          "K822786",
          "K833923",
          "K900302",
          "K902881",
          "K842008",
          "K830312",
          "K070340",
          "K790196",
          "K781616",
          "K844615",
          "K843360",
          "K930286",
          "K771975",
          "K840987",
          "K812338",
          "K821406",
          "K914778",
          "K955663",
          "K945485",
          "K791465",
          "K801146",
          "K870720",
          "K830311",
          "K811199",
          "K830310",
          "K905464",
          "K954015",
          "K897133",
          "K902632",
          "K930471",
          "K954035",
          "K801435",
          "K780939",
          "K875117",
          "K840986",
          "K820875",
          "K925453",
          "K830333",
          "K930986"
        ],
        "registration_number": [
          "3004519921",
          "1422634",
          "3004111573",
          "1223004",
          "1526863",
          "3004102403",
          "9617604",
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          "3002907620",
          "3006191977",
          "9616675",
          "1423537",
          "3005595283",
          "1061124",
          "9616567",
          "3012542015",
          "3020460367",
          "1718873"
        ],
        "fei_number": [
          "3004111573",
          "1526863",
          "3003105967",
          "3004102403",
          "1000138054",
          "3002902735",
          "3005846326",
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          "1928237",
          "1000514656",
          "1000374126",
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          "1643817",
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          "3015060216",
          "1713468",
          "1000512168",
          "3002806559",
          "1523456",
          "3002963732",
          "2025816",
          "3016707060",
          "3007329020",
          "3001236905",
          "3002558692",
          "2245270",
          "3005012805",
          "3005587132",
          "3009888344",
          "3002907620",
          "3006191977",
          "3005595283",
          "1000120555",
          "3012542015",
          "3020460367",
          "1718873"
        ],
        "device_name": "Arterial Blood Sampling Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.1100",
        "device_class": "1"
      }
    }
  ]
}