{
  "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": "196140",
      "product_res_number": "Z-0088-2023",
      "event_date_initiated": "2022-09-01",
      "event_date_posted": "2022-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2026-01-26",
      "res_event_number": "90889",
      "product_code": "OFF",
      "product_description": "VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF  VC-PPH-67A.  Cardiovascular procedure convenience kit.",
      "code_info": "UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024;\nUDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "reason_for_recall": "Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline Industries, LP sent a MEDICAL DEVICE RECALL notice to its consignees on 09/08/2022 by US Mail.  The notice identified the product, problem, and requested the following:  \n\"REQUIRED ACTION:\n1.Immediately check your stock for the affected item number and the affected lot numbers listedon the recall portal. Quarantine all affected product.\n2.Please use the link and the information below to complete your response form. Please list thequantity of affected product you have in inventory on the form. Even if you do not have anyaffected product in inventory, please complete and submit the form.\nThe login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-131-FG Recall Code: RXXXXXXX\n3.Upon receipt of your submitted response form, return labels and RGA information will beprovided, if applicable. Your account will receive credit when the returned product is received.\n4.If you are a distributor, or have resold or transferred this product to another company orindividual, you are required by FDA regulations to notify them of this recall communication.Have the customers return any affected product to you for collection and return to MedlineIndustries, LP.\nIf you have any questions, please contact the Recall Department at 866-359-1704.\"",
      "product_quantity": "1760 kits",
      "distribution_pattern": "CA",
      "openfda": {
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          "1423537",
          "1423395",
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        ],
        "fei_number": [
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          "1000160458",
          "3000717925",
          "3002902735",
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        ],
        "device_name": "Central Venous Catheter Tray",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1140",
        "device_class": "2"
      }
    }
  ]
}