{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204973",
      "product_res_number": "Z-0674-2024",
      "event_date_initiated": "2023-11-28",
      "event_date_posted": "2024-01-05",
      "recall_status": "Open, Classified",
      "res_event_number": "93617",
      "product_code": "MGB",
      "pma_numbers": [
        "P040044"
      ],
      "product_description": "MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.",
      "code_info": "UDI/DI 10862028000403, Lot numbers:  F2322902",
      "firm_fei_number": "1016427",
      "recalling_firm": "Cordis US Corp",
      "address_1": "14201 Nw 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2802",
      "additional_info_contact": "786-313-2000",
      "reason_for_recall": "Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903\n(MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.",
      "root_cause_description": "Labeling Change Control",
      "action": "Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX.  The notice explained the issue and requested the return of any affected product in inventory.\nFor questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com\nor call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.",
      "product_quantity": "50  units",
      "distribution_pattern": "US:  NC, WV, TN, MS, MI, OH, CA",
      "openfda": {
        "pma_number": [
          "P040044",
          "P050043",
          "P210017",
          "P990037",
          "P150022",
          "P040022",
          "P120016",
          "P010049",
          "P080029",
          "P230038",
          "P020035",
          "P930038",
          "P150006",
          "P050007",
          "P960043",
          "P920004",
          "P100013",
          "P180025"
        ],
        "registration_number": [
          "1118880",
          "3003898360",
          "3012977275",
          "1226183",
          "2953359",
          "1016427",
          "1721686",
          "3002907620",
          "2029275",
          "9616099",
          "3004939290",
          "2243441",
          "3008307705",
          "2022435",
          "3004091615",
          "3013394970",
          "2939561",
          "3015542130",
          "3012448339",
          "2024168",
          "3005718570",
          "3005334138",
          "3011137372",
          "3007766601",
          "2134812",
          "3012102437",
          "3011469355",
          "3009984513",
          "2183744",
          "3002807314",
          "1649518",
          "3008102042",
          "3015145497",
          "2011171",
          "1423662",
          "2246552"
        ],
        "fei_number": [
          "1118880",
          "3003898360",
          "3012977275",
          "3002757549",
          "1016427",
          "1721686",
          "3002907620",
          "2243441",
          "3008307705",
          "2022435",
          "3003528016",
          "3004091615",
          "1000306431",
          "3013394970",
          "3015542130",
          "3000215273",
          "3012448339",
          "2024168",
          "3005718570",
          "3005334138",
          "3007766601",
          "3012102437",
          "3011469355",
          "3002924544",
          "3010142363",
          "3009984513",
          "2183744",
          "3000215205",
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          "3005747797",
          "3015145497",
          "3002827704",
          "2011171",
          "2246552",
          "3001236277",
          "3004635528"
        ],
        "device_name": "Device, Hemostasis, Vascular",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}