{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194790",
      "product_res_number": "Z-1555-2022",
      "event_date_initiated": "2022-07-18",
      "event_date_created": "2022-08-18",
      "recall_status": "Open, Classified",
      "res_event_number": "90567",
      "product_code": "ONB",
      "k_numbers": [
        "K123213"
      ],
      "product_description": "BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.\nCatalog Number:  515304",
      "code_info": "UDI-DI: 30382905153045  Lot Numbers: 2007212, 2103205",
      "firm_fei_number": "2243072",
      "recalling_firm": "Becton Dickinson & Company",
      "address_1": "1 Becton Dr",
      "city": "Franklin Lakes",
      "state": "NJ",
      "postal_code": "07417-1815",
      "additional_info_contact": "SAME\n201-847-6800",
      "reason_for_recall": "Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.",
      "root_cause_description": "Employee error",
      "action": "BD issued Urgent Medical Device Recall letter on 7/18/22 to Distributors and Customers. via email or mail. Letter states reason for recall, health risk and action to take:\n1.\tImmediately review your inventory for the specific Catalog (Ref) and Lot numbers listed in table above and destroy following your institutions process for destruction.\n\n2.\tShare this notification with all users within your facility network of the product to ensure they are also aware of this field action. This recall notice should also be shared with any organization where the potentially affected products have been transferred.\n\n3.\tComplete the attached Customer Response Form and return form 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.\nBD Contact\tContact Information\tAreas of Support\nNorth American Regional Complaint Center\t1-844-8BD-LIFE (1-844-823-5433)\nSay  Recall  when prompted Mon Fri 8:00am and 5:00pm CT\nor productcomplaints@bd.com\tGeneral Follow-up, Product Complaints, Technical Questions",
      "product_quantity": "9,340 units",
      "distribution_pattern": "US Nationwide Distribution\nCA\nFL\nGA\nIL\nMD\nMI\nOR\nPA\nPR\nTN\nTX",
      "openfda": {
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          "K251722",
          "K243976",
          "K201142",
          "K240517",
          "K201422",
          "K140591",
          "K181221",
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          "K132899",
          "K251340",
          "K130197",
          "K241823",
          "K223076",
          "K141448",
          "K150219",
          "K192866",
          "K210707"
        ],
        "registration_number": [
          "3008729892",
          "3030733800",
          "1710034",
          "2243072",
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          "3013764800",
          "3012429465",
          "3002806603",
          "2025816"
        ],
        "fei_number": [
          "3030733800",
          "1710034",
          "2243072",
          "3030384100",
          "3012039263",
          "3010882708",
          "3008434487",
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          "3003058448",
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          "3013764800",
          "3008002452",
          "3012429465",
          "3002806603",
          "2025816",
          "3003807466"
        ],
        "device_name": "Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}