{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "123332",
      "product_res_number": "Z-0339-2014",
      "event_date_initiated": "2013-10-28",
      "event_date_posted": "2013-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-03",
      "res_event_number": "66763",
      "product_code": "GXQ",
      "k_numbers": [
        "K982282"
      ],
      "product_description": "Dura Guard, Dural Repair Patch with Apex Processing.\n\nFor use as a dura substitute for the closure of dura mater during neurosurgery.\n\nProduct Code:\n\nDG0209SN  \nDG0209SN   \nDG0209SN  \nDG0209SN   \nDG0209SN    \nDG0209SN    \nDG0209SN   \nDG0209SN   \nDG0404SN     \nDG0404SN     \nDG0404SN    \nDG0404SN    \nDG0404SN    \nDG0404SN    \nDG0404SN     \nDG0404SN    \nDG0404SN \nDG0404SN   \nDG0404SN   \nDG0404SN  \nDG0404SN     \nDG0404SN    \nDG0404SN   \nDG0608SN    \nDG0608SN     \nDG0608SN    \nDG0608SN   \nDG0608SN  \nDG0608SN     \nDG0608SN     \nDG0608SN     \nDG0608SN    \nDG0608SN    \nDG0608SN   \nDG0608SN   \nDG0608SN      \nDG0608SN      \nDG0608SN  \nDG0608SN    \nDG0608SN    \nDG0608SN    \nDG0608SN",
      "code_info": "Lot Numbers:  SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125",
      "firm_fei_number": "2183620",
      "recalling_firm": "Synovis Surgical Innovations, Inc.",
      "address_1": "2575 University Ave W",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55114-1073",
      "additional_info_contact": "651-796-7300",
      "reason_for_recall": "Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping",
      "root_cause_description": "Packaging change control",
      "action": "A customer notification letter dated 10/28/13 was sent to all customers who purchased the Vascu Guard and the Dura Guard.  The letter informs the customers of the problem identified and the actions to be taken.  Customers with any questions regarding the recall are instructed to contact Customer Service unit at (800) 423-2090.  If customers are distributors or if they have have distributed the recalled products to any other health care provider, they are instructed to notify their accounts and provide them with a copy of the recall notification. If customers would like Baxter to perform the recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417.",
      "product_quantity": "446 units",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "k_number": [
          "K041000",
          "K113071",
          "K150825",
          "K061487",
          "K072207",
          "K982180",
          "K212943",
          "K982282",
          "K061208",
          "K131015",
          "K250420",
          "K984534",
          "K132850",
          "K251191",
          "K172603",
          "K122791",
          "K183513",
          "K161370",
          "K960470",
          "K982101",
          "K223445",
          "K120600",
          "K141608",
          "K973706",
          "K980548",
          "K161278",
          "K041518",
          "K040888",
          "K021477",
          "K163456",
          "K950956",
          "K031850",
          "K043427",
          "K052211",
          "K991413",
          "K063117",
          "K970851",
          "K153613",
          "K032693",
          "K092388",
          "K131792",
          "K152481",
          "K953969"
        ],
        "registration_number": [
          "",
          "3030126381",
          "3002719998",
          "9610612",
          "2249852",
          "3012448339",
          "1835959",
          "3003418325",
          "2245304",
          "3035387162",
          "1319639",
          "1000393132",
          "3004681519",
          "3004170064",
          "3020659113",
          "1319660",
          "1220948",
          "2183620",
          "3003300673",
          "3000270450",
          "3002924436",
          "2650143",
          "3007284313",
          "3027448274",
          "2916714",
          "9681465",
          "9680260",
          "3012421607",
          "3008812560",
          "3025316685",
          "1121308",
          "3009039068",
          "3004464325",
          "1225991",
          "3006017180",
          "3012429393",
          "3002294946",
          "3034676720",
          "1416980",
          "3012479318",
          "2648988",
          "3009417901"
        ],
        "fei_number": [
          "",
          "2648209",
          "3030126381",
          "3002719998",
          "3002807113",
          "3012448339",
          "3003418325",
          "3002315844",
          "2245304",
          "3035387162",
          "1000393132",
          "3004170064",
          "3020659113",
          "3002340648",
          "1220948",
          "2183620",
          "3003870583",
          "3003300673",
          "3000270450",
          "3002924436",
          "3007284313",
          "3027448274",
          "2916714",
          "3012421607",
          "3002806315",
          "1000138054",
          "3008817245",
          "3008812560",
          "3025316685",
          "1121308",
          "3009039068",
          "1000136478",
          "3004464325",
          "3006017180",
          "3012429393",
          "3002516348",
          "3002294946",
          "3034676720",
          "1416980",
          "3012479318",
          "3000204775",
          "3009417901"
        ],
        "device_name": "Dura Substitute",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5910",
        "device_class": "2"
      }
    }
  ]
}