{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191965",
      "product_res_number": "Z-0729-2022",
      "event_date_initiated": "2022-01-14",
      "event_date_created": "2022-03-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-09-19",
      "res_event_number": "89573",
      "product_code": "MAL",
      "k_numbers": [
        "K954848"
      ],
      "product_description": "HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT-\nD: 7 mm; L: 60 cm\nIndicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.\n\n\nProduct Code/REF Number: M002020952070",
      "code_info": "Lot Number: 21B10\nS/N: 1318567653\n\nUDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10",
      "firm_fei_number": "2242352",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "reason_for_recall": "Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm",
      "root_cause_description": "Packaging process control",
      "action": "Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take:\nActions to be taken:\n\" If you have already implanted the above-mentioned device, kindly notify us as soon as possible by\ncontacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2),\nMonday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted\nshortly by our Medical Affairs Officer in order to discuss the appropriate follow up.\n\" Please examine your inventory immediately to determine if you have the HEMASHIELD GOLD\nProduct Knitted Microvel Double Velour Straight Vascular Graft (D: 7 mm; L: 60 cm) SN\n1318567653, Ref Number M002020952070.\n\" Should you have the un-used affected product, you are eligible for credit upon receipt of\nResponse Form (see page 4).\n\" Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through\nFriday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping\ninstructions to return any affected product.\n\" Pack the product to be returned with the appropriate return documents.\n\" Whether you have affected product or not, please complete and sign the attached URGENT\nMEDICAL DEVICE REMOVAL   RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashieldgold-\nRecall.us@getinge.com or by FAX to 8772811346.\n\n\" Please forward this information to all current and potential Hemashield Gold Knitted Microvel\nDouble Velour Vascular Graft users within your hospital / facility.\n\" If you are a distributor who has shipped any affected product to customers, please forward this document to their attention for appropriate action.\n\nIf you have any questions,\nplease contact your Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday th",
      "product_quantity": "1 unit",
      "distribution_pattern": "US Nationwide distribution in the state of MO.",
      "openfda": {
        "k_number": [
          "K021213",
          "K954848",
          "K122612",
          "K052302",
          "K093231",
          "K103080"
        ],
        "pma_number": [
          "P920027",
          "P890045"
        ],
        "registration_number": [
          "3010407203",
          "3010162973",
          "9612515",
          "1640201",
          "2246552",
          "1220948",
          "3045042524"
        ],
        "fei_number": [
          "3010407203",
          "3002807041",
          "3002707083",
          "2246552",
          "1220948",
          "3045042524",
          "3002808437"
        ],
        "device_name": "Graft, Vascular, Synthetic/Biologic Composite",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3450",
        "device_class": "2"
      }
    }
  ]
}