{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "184624",
      "product_res_number": "Z-0698-2021",
      "event_date_initiated": "2020-11-10",
      "event_date_created": "2020-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-09-03",
      "res_event_number": "86828",
      "product_code": "PIO",
      "k_numbers": [
        "K150034"
      ],
      "product_description": "AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. \n\nBox PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075",
      "code_info": "Box Lot Number 200918-103; Pouch Lot Number 200902-075",
      "firm_fei_number": "1526012",
      "recalling_firm": "Applied Medical Technology Inc",
      "address_1": "8006 Katherine Blvd",
      "city": "Brecksville",
      "state": "OH",
      "postal_code": "44141-4202",
      "additional_info_contact": "Charity Bell\n440-717-4000",
      "reason_for_recall": "The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.",
      "root_cause_description": "Labeling Change Control",
      "action": "On November 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that incorrect labels were used for the internal pouches of the devices subject to this recall, while the outer box has the correct label.\n\nCustomers were informed that a box containing pouches with lot number 200902-075 should be returned to Applied Medical Technology, Inc.\n\nCustomers were instructed to take the following immediate actions:\n\n- Do not use any device subject to this recall\n- Complete and return the enclosed acknowledgement form\n- Contact Applied Medical Technology, Inc. to make arrangements for the return of any devices related to the recall.\n- Continue to inspect and prepare any devices prior to use according to its standard operating procedures and good medical practices.",
      "distribution_pattern": "US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.",
      "openfda": {
        "k_number": [
          "K233190",
          "K140581",
          "K162254",
          "K220165",
          "K231299",
          "K150034",
          "K150010",
          "K151237",
          "K151628"
        ],
        "device_name": "Enteral Specific Transition Connectors",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2",
        "registration_number": [
          "1526012",
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}