{
  "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": "31748",
      "product_res_number": "Z-0638-04",
      "event_date_initiated": "2003-12-30",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-01-19",
      "res_event_number": "28388",
      "product_code": "DSY",
      "k_numbers": [
        "K983819"
      ],
      "product_description": "HemaCarotid Patch, Ultrathin, Collagen Coated  Knitted Polyester Vascular Patch.\n\nProduct Catalog Numbers: \nHEK06/75CPUT;\nHEK08/75CPUT;\nHEK14/75CPUT;\nHEK08/120CPUT;\nHEK10/75CPUT;\nHEK25/100CPUT;\nHEK12/75CPUT;\nHEK10/150CPUT.",
      "code_info": "Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.",
      "firm_fei_number": "2221819",
      "recalling_firm": "Datascope Corporation",
      "address_1": "14 Philips Pkwy",
      "city": "Montvale",
      "state": "NJ",
      "postal_code": "07645-1811",
      "additional_info_contact": "Mr. Vincent Cafiso\n201-307-5476",
      "reason_for_recall": "Water permeability of the patch is out of specification.",
      "root_cause_description": "Other",
      "action": "Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.",
      "product_quantity": "710 units",
      "distribution_pattern": "The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.",
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        "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3450",
        "device_class": "2"
      }
    }
  ]
}