{
  "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": "183805",
      "product_res_number": "Z-0294-2021",
      "event_date_initiated": "2020-09-14",
      "event_date_created": "2020-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-11-09",
      "res_event_number": "86477",
      "product_code": "PND",
      "k_numbers": [
        "K162900"
      ],
      "product_description": "Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media\nRef: P6153118",
      "code_info": "Lot Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027",
      "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": "Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Becton Dickinson (BD) issued notification letter to FSN Europe on  9/14/20 to customer stating reason for recall, health risk and action to take specific to the country:\nAdvice on actions to be taken by the Distributor:\n1. Inspect your inventory, locate and quarantine any units of the impacted devices listed in Table 1.\n2. If you have further distributed the product, please identify those facilities, notify them at once of this product removal and have them return the affected product to your facility.\n3. Destroy any unused units of the affected product and complete the customer response form on page 3 indicating:\no the quantities destroyed OR\no that your organisation does not have any impacted units left in inventory\n4. Return the completed Customer Response Form to <> as soon as possible or no later than October 9th, 2020.\nShould you have any questions or require assistance relating to this Field Safety Notice, please contact your Local BD representative at <>",
      "product_quantity": "45 units OUS only",
      "distribution_pattern": "Foreign:  Italy, Spain, and UK",
      "openfda": {
        "k_number": [
          "K170770",
          "K252402",
          "K170158",
          "K153393",
          "K213855",
          "K192802",
          "K181208",
          "K171483",
          "K210047",
          "K162900",
          "K213203",
          "K161313",
          "K173114"
        ],
        "registration_number": [
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          "3009888344",
          "1220477",
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          "3013666218",
          "3015859709",
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          "3004102031",
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          "1061124",
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          "3007137787",
          "1018233",
          "1721686",
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          "2246552",
          "1223004",
          "9680794",
          "3006082230",
          "3015537049",
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        ],
        "fei_number": [
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          "3009888344",
          "1220477",
          "2245270",
          "3013666218",
          "1000306216",
          "3015859709",
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          "2518902",
          "2246552",
          "3006082230",
          "3015537049",
          "3003915875",
          "3000206435"
        ],
        "device_name": "Midline Catheter",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}