{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193733",
      "product_res_number": "Z-1273-2022",
      "event_date_initiated": "2022-04-22",
      "event_date_created": "2022-06-21",
      "recall_status": "Open, Classified",
      "res_event_number": "90201",
      "product_code": "PXI",
      "product_description": "REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,",
      "code_info": "Lot # 0001405396; UDI/DI: (01)10885403076114",
      "firm_fei_number": "2020394",
      "recalling_firm": "Bard Peripheral Vascular Inc",
      "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St",
      "address_2": "Bldg 1",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85281-2438",
      "additional_info_contact": "North America Regional Complaint Center\n480-303-2602",
      "reason_for_recall": "There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods:\nUniversal extension set and drainage bag, vacuum bottle, and wall suction.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On March 18, 2022, Bard Peripheral Vascular issued a \"Urgent Medical Device Correction\" notification to affected consignees via E-Mail or Fed Ex. The notification ask consignees to take the following actions: \n\n1. Please check all inventory locations within your institution for the product listed in Table A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facility s destruction process.\n\n2. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action.\n\n3. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution.\n\n4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement or credit.\n\n5. Indicate on the response form the quantity of affected product identified at your facility and confirm that this inventory was destroyed.\n\n6. Please contact your BD representative to assist in this process or you may also contact the number for further assistance.\n\n7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch; Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787",
      "product_quantity": "1460 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.",
      "openfda": {
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          "1018233",
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        "fei_number": [
          "1000512168",
          "1643817",
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        ],
        "device_name": "Thoracentesis Tray",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5570",
        "device_class": "2"
      }
    }
  ]
}