{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121842",
      "product_res_number": "Z-0143-2014",
      "event_date_initiated": "2013-09-10",
      "event_date_posted": "2013-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-06-05",
      "res_event_number": "66249",
      "product_code": "OBK",
      "product_description": "Dual Luer Lock Cap\r\n\r\nThe device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.",
      "code_info": "10043, 10044",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.",
      "root_cause_description": "Employee error",
      "action": "Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nCustomers were advised to :\r\n\r\n1. Locate and remove all affected product from your facility.   If  you distribute these products to other facilities or departments  within your institution, please forward a copy of this  communication to ensure that they locate and remove affected product from potential use.The product  code and lot number  can  be  found on the shipping carton label and individual product package.\r\n\r\n2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing  it  to  fca@baxter.com. Returning the  Customer  Reply Form promptly will prevent you from receiving repeat notifications.\r\n\r\n3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time.  Please have your Baxter eight-digit ship-to account number  ready when calling.   Please have the  product code and lot number(s) available.\r\n\r\n4.If you are a dealer, wholesaler,or distributor/reseller  that distributed  any  product  to  other  facilities,  please  forward  this communication. Baxter  distributed  this  product  to  customers between June 19, 2013 and August 20, 2013.\r\n\r\nThe Center for One Baxter is available at 1-800-422-9837, Monday through\r\nFriday during the hours of 8:00 am to 5:00 pm Central Time.",
      "product_quantity": "628,992 units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the country of Canada.",
      "openfda": {
        "device_name": "Port, Protector/Cushion",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5965",
        "device_class": "2",
        "k_number": [
          "K062261"
        ]
      }
    }
  ]
}