{
  "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,
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  "results": [
    {
      "cfres_id": "64529",
      "product_res_number": "Z-0078-2008",
      "event_date_initiated": "2007-09-18",
      "event_date_posted": "2007-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-01-25",
      "res_event_number": "44915",
      "product_code": "LKN",
      "k_numbers": [
        "K071079"
      ],
      "product_description": "Spectra Optia apheresis system, a blood component separator.  Part No. 61000, Gambro BCT Lakewood, CO USA 80215.",
      "code_info": "Part No. 61000, Serial Numbers 1P00100 to 1P00141.",
      "firm_fei_number": "1000117351",
      "recalling_firm": "Gambro BCT, Inc.",
      "address_1": "10811 W Collins Ave",
      "city": "Lakewood",
      "state": "CO",
      "postal_code": "80215-4440",
      "additional_info_contact": "303-231-4180",
      "reason_for_recall": "Under specific conditions, apheresis machine could return up to 60mL of air to the patient.",
      "root_cause_description": "Software design",
      "action": "All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.",
      "product_quantity": "15 units",
      "distribution_pattern": "US, Canada, Australia, Europe.",
      "openfda": {
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        "device_name": "Separator, Automated, Blood Cell And Plasma, Therapeutic",
        "medical_specialty_description": "Unknown",
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