{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "95762",
      "product_res_number": "Z-0616-2011",
      "event_date_initiated": "2010-10-18",
      "event_date_posted": "2010-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-10-05",
      "res_event_number": "57290",
      "product_code": "LKN",
      "product_description": "Fresenius  Red Blood Cell Set, Catalog Number 9007601.\n\nThe product is labeled in part: \"RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands\".\n\nIntended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.",
      "code_info": "Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.",
      "firm_fei_number": "3007344667",
      "recalling_firm": "Fresenius Kabi, LLC",
      "address_1": "8635 154th Ave NE",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-3564",
      "additional_info_contact": "800-909-3872",
      "reason_for_recall": "Potential for patient hematocrit dropped to levels lower than expected post-treatment.",
      "root_cause_description": "Device Design",
      "action": "On October 21, 2010, Fresenius Kabi, LLC in Redmond, WA sent a \"Field Safety Corrective Action\" Letter  dated October 18, 2010 to their US Consignees/Customers.  On October 22, 2010,  the firm followed up with their customers by telephone call.\n\nThe letter informed the consignees/customers that the Red Blood Cell (RBC) exchange sets for use on the AS104 Blood Cell Separation Device are being recalled.\n\nThe consignees/customers were advised to examine their stock and determine if they have any affected products on hand.  They were instructed to discontinue distributing, using, dispensing the affected products, and return the product to Fresenius Kabi, LLC, 8635 154th Avenue, NE, Redmond, WA 98052.\n\nThe consignees/customers were also instructed to notify their sub-account customers if the products were further distributed and to complete the Product Recall Response Form and fax it back to 425-242-2101.   T\n\nIf you have any further questions concerning the recall, please contact the Quality Assurance Manager at 800-909-3872.",
      "product_quantity": "255 units.",
      "distribution_pattern": "Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.",
      "openfda": {
        "k_number": [
          "K192150",
          "K103090",
          "K181049",
          "K071079",
          "K132429",
          "K830831",
          "K131744",
          "K953681",
          "K183081",
          "K180615",
          "K050273",
          "K961706",
          "K895435",
          "K874607",
          "K926409",
          "K831004",
          "K172590",
          "K113480",
          "K060734",
          "K153601",
          "K900105",
          "K893962",
          "K850621",
          "K151368",
          "K141938",
          "K141019",
          "K111702"
        ],
        "pma_number": [
          "P820002",
          "P820032",
          "P830010",
          "P850020",
          "P810023",
          "P850092"
        ],
        "device_name": "Separator, Automated, Blood Cell And Plasma, Therapeutic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "registration_number": [
          "2029015",
          "1720929",
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          "3020981987"
        ]
      }
    }
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}