{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "160660",
      "product_res_number": "Z-0411-2018",
      "event_date_initiated": "2017-12-21",
      "event_date_created": "2018-01-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-04",
      "res_event_number": "78835",
      "product_code": "FLD",
      "k_numbers": [
        "K133807"
      ],
      "product_description": "MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541",
      "code_info": "UDI:  37332414107728; Lot Numbers:  0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "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": "Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm initiated their recall on 12/21/2017 by letter.  The recall notice stated the following actions to be taken by the customers:\n\"1. Locate and remove all affected product from your facility. The product code\nand lot number can be found on the individual MARS Treatment Kit box.\n2. Contact Baxter Healthcare Center for Service to arrange for return and credit.\nBaxter Healthcare Center for Service can be reached at 888-229-0001\nbetween the hours of 7:00 am and 6:00 pm Central Time, Monday through\nFriday. Please have your Baxter 8-digit ship-to account number, product code,\nlot number, and quantity of product to be returned ready when calling.\n3. If you purchased this product directly from Baxter, complete the enclosed\nBaxter customer reply form and return it to Baxter by faxing it to 224-270-\n5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have\nany inventory.\"",
      "product_quantity": "186 units",
      "distribution_pattern": "US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France,\nRussia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.",
      "openfda": {
        "k_number": [
          "K971015",
          "K113313",
          "K831029",
          "K873643",
          "K133807",
          "K885017",
          "K033262",
          "K992196",
          "K840532",
          "K984546",
          "K953751"
        ],
        "registration_number": [
          "3038195011",
          "1319660",
          "3008822486",
          "3014015528",
          "3030956240",
          "2183828",
          "3006174295",
          "9611369",
          "3032828299",
          "3011228909",
          "2245304",
          "1319639"
        ],
        "fei_number": [
          "3038195011",
          "3008822486",
          "3014015528",
          "3030956240",
          "2183828",
          "1000138054",
          "3006174295",
          "3032828299",
          "3011228909",
          "3002807035",
          "2245304",
          "1000136478"
        ],
        "device_name": "Apparatus, Hemoperfusion, Sorbent",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5870",
        "device_class": "2"
      }
    }
  ]
}