{
  "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": "203422",
      "product_res_number": "Z-0182-2024",
      "event_date_initiated": "2023-09-01",
      "event_date_posted": "2023-10-26",
      "recall_status": "Open, Classified",
      "res_event_number": "93086",
      "product_code": "NWU",
      "product_description": "Cath Cardiac Pack, REF IHCC03V",
      "code_info": "UDI/DI 00191072189431, Lot Numbers:  724221, 679221, 945231",
      "firm_fei_number": "3003309947",
      "recalling_firm": "American Contract Systems, Inc.",
      "address_1": "7802 E Telecom Pkwy",
      "city": "Temple Terrace",
      "state": "FL",
      "postal_code": "33637-0928",
      "additional_info_contact": "Marlene Jones \n470-280-4277",
      "reason_for_recall": "During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and \nAdhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.",
      "root_cause_description": "Process control",
      "action": "Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email.  The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory.  \n\nThe firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.",
      "product_quantity": "1260 units",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IA.",
      "openfda": {
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        "k_number": [
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          "K874045",
          "K813332"
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        "device_name": "Endoscope Introducer Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}