{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74625",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide including Puerto Rico, and outside the US to include:  Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.",
      "recall_number": "Z-2533-2016",
      "product_description": "Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:   1 cm x 6 cm, product code VG0106N,   0.8 cm x 8 cm, product code VG0108N,   1 cm x 10 cm, product code VG0110N, and   2 cm x 9 cm, product code VG0209N.    VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde.  Sterilized using aseptic processing techniques.  The pericardium is procured from cattle originating in the United States.  VASC-Guard is chemically sterilized using ethanol and propylene oxide.      UPDATE 9/1/2016  Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:   1 cm x 6 cm, product code VG0106N,   0.8 cm x 8 cm, product code VG0108N.",
      "product_quantity": "32,763 eaches  UPDATE 9/1/2016  2,042 eaches",
      "reason_for_recall": "Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch.  Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention.  One report involved a case with a fatal outcome.      UPDATE  9/1/2016  Baxter issued a notice retrieving 6 lots of VASCU-GUARD  due to the increased postmarketing reports related to intraoperative and postoperative bleeding.",
      "recall_initiation_date": "20160624",
      "center_classification_date": "20160812",
      "termination_date": "20170623",
      "report_date": "20160824",
      "code_info": "Product Code VG0106N, Lot #:  SP16A04-1108933, SP16A11-1111696, SP16A12-1111933, SP16A12-1111938, SP16A12-1111942, SP16A12-1111947, SP16A27-1116312, SP16A29-1116884, SP16B04-1118465, SP16B08-1119650, SP16B12-1121361, SP16B22-1123979, SP16B24-1124658, SP16C01-1126439, SP16C01-1126508, SP16C07-1128790, SP16C08-1129067, SP16C09-1129905, SP16C10-1130129, SP16C10-1130134, SP16C23-1134739, SP16C28-1136324, SP16C28-1136332, SP16D06-1139370, SP16D13-1141301, SP16D19-1142941, SP16D20-1143649, SP16D20-1143655, SP16D21-1143852, SP16D28-1146476, SP16E04-1148533, SP16E04-1148534, SP16E19-1152299, SP16E24-1153675, SP16F01-1155425, SP16F01-1155678, SP16F01-1155682, SP16F01-1155685.      Product Code VG0108N, Lot #:  SP16A04-1108941, SP16A04-1108956, SP16A04-1108974, SP16A06-1110391, SP16A12-1111872, SP16A12-1111952, SP16A14-1112703, SP16A14-1112720, SP16A18-1113372, SP16A19-1114051, SP16A19-1114056, SP16A21-1114800, SP16A21-1114802, SP16A21-1114805, SP16B04-1118471, SP16B04-1118475, SP16B05-1119212, SP16B05-1119217, SP16B08-1119654, SP16B08-1119720, SP16B12-1121365, SP16B12-1121366, SP16B19-1123365, SP16B22-1123983, SP16B25-1125254, SP16B25-1125260, SP16B25-1125268, SP16C01-1126459, SP16C07-1128755, SP16C08-1129301, SP16C10-1130184, SP16C10-1130191, SP16C10-1130200, SP16C10-1130208, SP16C10-1130219, SP16C10-1130227, SP16C16-1132096, SP16C18-1133115, SP16C18-1133138, SP16C18-1133148, SP16C18-1133152, SP16C18-1133155, SP16C18-1133157, SP16C21-1133807, SP16C22-1134481, SP16C24-1135156, SP16C28-1136307, SP16C28-1136436, SP16D01-1137764, SP16D04-1138414, SP16D04-1138417, SP16D12-1140707, SP16D12-1140708, SP16D19-1142958, SP16D19-1142967, SP16D21-1143872, SP16D21-1143878, SP16D28-1146462, SP16D28-1146466, SP16D28-1146471, SP16E04-1148520, SP16E04-1148522, SP16E04-1148549, SP16E05-1148667, SP16E11-1150104, SP16E11-1150110, SP16E11-1150115, SP16E11-1150174, SP16E19-1152326, SP16E19-1152330, SP16E19-1152335, SP16E24-1153278, SP16E24-1153280, SP16E26-1154142, SP16E26-1154146, SP16E27-1154532, SP16E27-1154534, SP16F01-1155407, SP16F07-1157497, SP16F07-1157505, SP16F07-1157513.      Product Code VG0110N, Lot #:   SP16A12-1111926, SP16A12-1111931, SP16A20-1114346, SP16B22-1123992, SP16C08-1129312, SP16C08-1129329, SP16C09-1129911, SP16C25-1135841, SP16D11-1140274, SP16D11-1140284, SP16D20-1143641, SP16D20-1143643, SP16D25-1144838, SP16E11-1150202, SP16F07-1157244, SP16F07-1157253, SP16F07-1157260.      Product Code VG0209N, Lot #:   SP16A04-1108918, SP16A12-1112283, SP16A12-1112284, SP16A20-1114352, SP16A21-1114790, SP16B15-1121467, SP16B22-1124000, SP16B25-1125139, SP16C08-1129339, SP16C08-1129346, SP16C14-1131192, SP16C16-1132144, SP16D01-1137778, SP16D11-1140290, SP16D18-1142652, SP16D20-1143633, SP16D20-1143638, SP16D28-1146487, SP16D28-1146606, SP16E04-1148530, SP16E11-1150205, SP16E19-1152309, SP16E27-1154668, SP16E27-1154693, SP16F08-1157871.      UPDATE 9/1/2016  the following lots are being retrieved for return to Baxter:  Product Code VG0106N:  Lot #:  SP16C09-1129905.  Product Code VG0108N:  Lot #:  SP16B08-1119720, SP16C18-1133152, SP16D04-1138417, SP16D28-1146462, SP16E04-1148522."
    }
  ]
}