{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "217708",
      "product_res_number": "Z-1157-2026",
      "event_date_initiated": "2025-11-03",
      "event_date_posted": "2026-01-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98145",
      "product_code": "CAK",
      "k_numbers": [
        "K960993"
      ],
      "product_description": "SQ40S Blood Transfusion Filter",
      "code_info": "Product Number: SQ40S\nUDI-DI code: 10887691000666\nLot Number: 7536142",
      "firm_fei_number": "2013342",
      "recalling_firm": "GVS TM, Inc",
      "address_1": "1630 W Industrial Park St",
      "city": "Covina",
      "state": "CA",
      "postal_code": "91722-3419",
      "additional_info_contact": "Jeff Weathers\n516-484-5400",
      "reason_for_recall": "Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.",
      "root_cause_description": "Process control",
      "action": "On 11/03/2025, the firm sent via email a \"GVS TM Inc Customer Statement\" informing customers that GVS TM Inc discovered that some of the products in the affected lot may have been damaged during the transportation process.  To avoid any potential risk this damage may pose to the downstream user, the firm is requesting return of the affected products.\n\nOn 11/18/2025, the firm sent via email a \"GVS TM Inc Product Recall Statements\" informing customers that the products were distributed before completion of the required quality control release process, including final review of sterilization documentation and Certificate of Analysis.  As a result the sterility assurance cannot be confirmed.\n\nCustomers are instructed to:\n1) Return all units of Lot 7536142 to GVS TM Inc - Customer Service using GVS TM FedEx Account 203742698, or\n2) Destroy the affected units at their facility according to their internal disposal procedures for medical devices.\n3) Confirmation Required\n - If Returning Product\n--Quantity returned\n--Date Shipped Back\n--Contact Person\n - If Destroying Product (Proof of Destruction Required)\n--Signed destruction confirmation\n--Statement on facility letterhead indicating:\n---Quantity destroyed\n---Date of Destruction\n---Method of disposal\n---Name/title of the person performing destruction\n\nUpon receipt of the above information, GVS TM Inc will issue replacements or credit depending on customer's preference.\n\nQuestions - Contact GVS TM Customer Service at customerservice tm.na@gvs.com",
      "product_quantity": "2,720 filters",
      "distribution_pattern": "U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA",
      "openfda": {
        "k_number": [
          "K960993",
          "K896203",
          "K972159",
          "K760165",
          "K830057",
          "K982822",
          "K000719",
          "K851370",
          "K823261",
          "K812697",
          "K904221",
          "K873667",
          "K873666",
          "K061103",
          "K955515",
          "K890844",
          "K896976",
          "K855064",
          "K970225",
          "K022477",
          "K830014",
          "K812874",
          "K760222",
          "K811985",
          "K896664",
          "K780145",
          "K864636",
          "K770253",
          "K810855",
          "K990310",
          "K854259",
          "K873792",
          "K873873",
          "K901887",
          "K904223",
          "K810761"
        ],
        "device_name": "Microfilter, Blood Transfusion",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2",
        "registration_number": [
          "9710488",
          "3004548776",
          "3003775072",
          "9612051",
          "3014936217",
          "3016844398",
          "1526534",
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          "3017174574",
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          "2013342",
          "3004548776",
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      }
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}