{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177199",
      "product_res_number": "Z-0415-2020",
      "event_date_initiated": "2019-10-03",
      "event_date_created": "2019-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-13",
      "res_event_number": "84108",
      "product_code": "MQF",
      "k_numbers": [
        "K983594"
      ],
      "product_description": "Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.",
      "code_info": "Lot Number 9502915",
      "firm_fei_number": "1820334",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "city": "Bloomington",
      "state": "IN",
      "postal_code": "47404-9120",
      "additional_info_contact": "Cook Medical Customer Relations Department\n812-339-2235",
      "reason_for_recall": "Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter.  Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers.  The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form.\nReturned Product should be addressed to:\nCook Medical EUDC\nRobert-Koch-Strae, 2\n52499 Baesweiler\nGERMANY\nCredit will be provided for the returned affected products where applicable.",
      "product_quantity": "202",
      "distribution_pattern": "No US distribution.\n\nThe products were distributed to the following foreign countries:  Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.",
      "openfda": {
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          "K023017",
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          "K172051",
          "K990350",
          "K033084",
          "K141666",
          "K192540",
          "K191015",
          "K173431",
          "K990349"
        ],
        "registration_number": [
          "3037001927",
          "9617744",
          "3010155661",
          "3017247483",
          "3043639843",
          "3008456389",
          "3005987240",
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          "1424263",
          "1825146"
        ],
        "fei_number": [
          "3037001927",
          "3010155661",
          "3003015552",
          "3017247483",
          "3006279007",
          "3043639843",
          "3008456389",
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          "1018470",
          "3002807969",
          "3014755376",
          "3003995932",
          "1820334",
          "1825146"
        ],
        "device_name": "Catheter, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6110",
        "device_class": "2"
      }
    }
  ]
}