{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "198639",
      "product_res_number": "Z-1254-2023",
      "event_date_initiated": "2023-02-14",
      "event_date_posted": "2023-03-15",
      "recall_status": "Open, Classified",
      "res_event_number": "91704",
      "product_code": "LKN",
      "k_numbers": [
        "K180615"
      ],
      "product_description": "Amicus MNC Apheresis Kit   Double Needle. Component of Amicus Separator multiprocedural apheresis platform",
      "code_info": "Product Code X6R2326; UDI: 04086000100144; Batch Numbers: FA22G25121, FA22H22134, FA22I26141, FA22J25225, FA22J31074.  \n\nThe Lot number coding system is the following:  FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.",
      "firm_fei_number": "3004548776",
      "recalling_firm": "Fenwal Inc",
      "address_1": "3 Corporate Dr Ste 300 3 Corporate Dr",
      "address_2": "Ste 300",
      "city": "Lake Zurich",
      "state": "IL",
      "postal_code": "60047-8930",
      "additional_info_contact": "Matt Kuhn\n847-550-5751",
      "reason_for_recall": "Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.",
      "root_cause_description": "Process control",
      "action": "Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery.  Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.",
      "product_quantity": "1,614 units",
      "distribution_pattern": "Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.",
      "openfda": {
        "k_number": [
          "K961706",
          "K850621",
          "K103090",
          "K953681",
          "K071079",
          "K113480",
          "K111702",
          "K181049",
          "K141938",
          "K830831",
          "K132429",
          "K131744",
          "K183081",
          "K180615",
          "K153601",
          "K151368",
          "K172590",
          "K874607",
          "K831004",
          "K141019",
          "K192150",
          "K893962",
          "K926409",
          "K060734",
          "K900105",
          "K050273",
          "K895435"
        ],
        "pma_number": [
          "P820032",
          "P810023",
          "P850092",
          "P830010",
          "P820002",
          "P850020"
        ],
        "device_name": "Separator, Automated, Blood Cell And Plasma, Therapeutic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "registration_number": [
          "9617787",
          "3010273872",
          "3020981987",
          "3003464075",
          "2029015",
          "1450662",
          "3004634229",
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        "fei_number": [
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          "3020981987",
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      }
    }
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}