{
  "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,
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  "results": [
    {
      "cfres_id": "205287",
      "product_res_number": "Z-0799-2024",
      "event_date_initiated": "2023-12-20",
      "event_date_posted": "2024-01-25",
      "recall_status": "Open, Classified",
      "res_event_number": "93679",
      "product_code": "FEG",
      "k_numbers": [
        "K960176"
      ],
      "product_description": "Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160",
      "code_info": "UDI/DI 00801741113253, Lot/Serial Numbers: NGDX0520, NGES3426, NGET0807, NGET1424, NGEX0089, NGEX1018, NGEY0581, NGEZ0909, NGEZ2672, NGFN1384, NGFN2360, NGFP3401, NGFS4432, NGFT1896, NGFT3418, NGFT5962, NGFV3515, NGFW1858, NGFX0157, NGFX5613, NGGP3235, NGGR2656, NGGX5810, NGHP2260",
      "firm_fei_number": "1018233",
      "recalling_firm": "C.R. Bard Inc",
      "address_1": "8195 Industrial Blvd Ne",
      "city": "Covington",
      "state": "GA",
      "postal_code": "30014-1497",
      "additional_info_contact": "770-784-6100",
      "reason_for_recall": "BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.",
      "root_cause_description": "Under Investigation by firm",
      "action": "BD (C.R. Bard) issued an URGENT Medical Device Recall Notice to its consignees via FedEx and email.  The notice explained the problem with the devices, potential risks, and the devices be removed, quarantined, and discarded.  Disseminate the notice to all users within the facility. \nIf you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product.\nComplete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit or alternate product.\n\nIn addition to the information above, Distributors were directed to take the following actions:\nPlease discontinue distribution of all product codes in the table above, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process.\n2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Attachment 2\n3. Complete the attached Distributor Response Form and return to the BD contact noted on the form confirming acknowledgement of the recall notification, whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification.\n4. Indicate on the response form the quantity of product identified at your facility and confirm that this inventory was destroyed. Attachment 1\n5. Please contact your BD representative if you require assistance with credits to be issued for discarded products or for replacement product options. You may also contact the number below for further assistance.",
      "product_quantity": "51750 units",
      "distribution_pattern": "US",
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          "K880850",
          "K921104",
          "K171619",
          "K040388",
          "K960176"
        ],
        "device_name": "Tube, Double Lumen For Intestinal Decompression And/Or Intubation",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2",
        "registration_number": [
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