{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "WAYNE",
      "address_1": "45 BARBOUR POND DR",
      "reason_for_recall": "Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).",
      "address_2": "",
      "product_quantity": "1 unit",
      "code_info": "Lot Code: 18K31  Serial Number: 1190443415  Part Number: M00202166168P0  UDI Code: 00384401018452",
      "center_classification_date": "20190923",
      "distribution_pattern": "US state of NJ",
      "state": "NJ",
      "product_description": "The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a  softening agent.",
      "report_date": "20191002",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GETINGE US SALES LLC",
      "recall_number": "Z-2559-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "83664",
      "termination_date": "20200427",
      "more_code_info": "",
      "recall_initiation_date": "20190822",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}