{
  "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": "2026-08-15",
    "results": {
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  "results": [
    {
      "cfres_id": "111813",
      "product_res_number": "Z-0431-2013",
      "event_date_initiated": "2012-07-26",
      "event_date_posted": "2012-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-10-29",
      "res_event_number": "62834",
      "product_code": "LMF",
      "pma_numbers": [
        "P050044"
      ],
      "product_description": "Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat.\n\nSterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.",
      "code_info": "Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.",
      "firm_fei_number": "1000307073",
      "recalling_firm": "Stryker Orthobiologics, Inc.",
      "address_1": "45 Great Valley Pkwy",
      "city": "Malvern",
      "state": "PA",
      "postal_code": "19355-1302",
      "additional_info_contact": "Customer Support\n610-640-1775",
      "reason_for_recall": "When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step.  Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe.  T",
      "root_cause_description": "Device Design",
      "action": "Stryker sent a \"MEDICAL DEVICE FIELD CORRECTION\" dated July 26, 2012 to all affected customers.  The letter identified the product, problem, and actions to be taken by the customers.  The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.",
      "product_quantity": "3,268",
      "distribution_pattern": "Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV",
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          "P990004",
          "P990030",
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          "P850023",
          "P810006",
          "N18286",
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          "P990009",
          "P830079"
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        "device_name": "Agent, Absorbable Hemostatic, Collagen Based",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4490",
        "device_class": "3"
      }
    }
  ]
}