{
  "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": "95766",
      "product_res_number": "Z-0844-2011",
      "event_date_initiated": "2010-11-19",
      "event_date_posted": "2011-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-11-03",
      "res_event_number": "57293",
      "product_code": "FJK",
      "k_numbers": [
        "K962081"
      ],
      "product_description": "Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7",
      "code_info": "Lots 09JR01174, 09JR01229, 09NR01139, 10KR01801",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "SAME\n800-662-1237",
      "reason_for_recall": "Hemodialysis Blood tubing Sets may develop kinking of the arterial line.",
      "root_cause_description": "Device Design",
      "action": "Fresenius Medical issued recall notification dated 11/19/10, \"URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)\", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.",
      "product_quantity": "10, 032 units (418 cases x 24 units)",
      "distribution_pattern": "Distribution Nationwide and Canada",
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        "device_name": "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
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}