{
  "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,
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  "results": [
    {
      "cfres_id": "216795",
      "product_res_number": "Z-0887-2026",
      "event_date_initiated": "2025-11-06",
      "event_date_posted": "2025-12-05",
      "recall_status": "Open, Classified",
      "res_event_number": "97864",
      "product_code": "PXI",
      "product_description": "Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,",
      "code_info": "UDI/Lot/Expiration:\n(01)10885403108365(17)271130(10)0001623320/0001623320/20271130;\n(01)10885403108365(17)271130 (10)0001623069/0001623069/20271130",
      "firm_fei_number": "2020394",
      "recalling_firm": "Bard Peripheral Vascular Inc",
      "address_1": "1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy.",
      "address_2": "Bldg 1",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85281-2438",
      "additional_info_contact": "480-303-2602",
      "reason_for_recall": "Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.",
      "root_cause_description": "Process control",
      "action": "On 11/06/2025, Medical Device Product Removal Notices were mailed to Health Care Professionals (HCPs), Risk Managers, Head Nurses, Nurse Managers, Medical Device Safety Officers, Procurement Officers, and Office Managers informing them of the following:\n\nDiscontinue use of product listed in the letter and immediately dispose of all affected product remaining in your possession in accordance with your local facility's process.\n\nShare this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please ensure  that these entities are contacted and informed of the recall.\n\nIf you purchased this product from a distributor, contact your distributor for further instructions and product resolution.\n\nComplete and return the attached Customer Response Form and return via email to BDRC28@bd.com \n\nAffected product complaints can be reported via email: productcomplaints@bd.com",
      "product_quantity": "1240",
      "distribution_pattern": "US Nationwide distribution in the states of CA, MN, IN, MI, LA.",
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        "device_name": "Thoracentesis Tray",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5570",
        "device_class": "2"
      }
    }
  ]
}