{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "159183",
      "product_res_number": "Z-0233-2018",
      "event_date_initiated": "2017-06-01",
      "event_date_created": "2017-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-07-19",
      "res_event_number": "77673",
      "product_code": "FPY",
      "product_description": "BLUE BURN SHEET, STERILE, 60\" x 96\"; Item 7305, GAM item 30-01\n\nProduct Usage - May provide a sterile, barrier environment to protect patient from infection.",
      "code_info": "Lot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408, JT31408, JT33508, JT00609, JT04809, JT15209, JT18209, JT19209, JT22409, JT22709, JT23209, JT25309, JT25809, JT27509, JT30109, JT31309, JT32909, JT17510, JT23610, JT24010, JT24810, JT30810, JT35910, JT00811, JT05011, JT07911, JT11511, JT15911, JT17011, JT18211, JT21511, JT26311, JT28411, JT30711, JT00812, JT07312, JT11812, JT13612, JT17712, JT21812, JT25612, JT33012, JT36112, JT36212, JT09113, JT17513, JT24713, JT29813, JT33513, JT01614, JT04614, JT06814",
      "firm_fei_number": "1000137528",
      "recalling_firm": "Dukal Corp.",
      "address_1": "2 Fleetwood Ct",
      "city": "Ronkonkoma",
      "state": "NY",
      "postal_code": "11779-6907",
      "additional_info_contact": "Richard Lanzillotto\n631-656-3800",
      "reason_for_recall": "Intact carton revealed presence of shredded burn sheets",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On May 30, 2017 Dukal sent an Urgent Product Recall notices and response forms to customers via UPS Overnight mail.  On June 5, 2017 an amended recall notice was sent to customers to identify the correct the item number which is 7305.  Customers were advised to do the following:\n1.\tEmail or fax the enclosed return card by June 30, 2017.\n2.\tImmediately segregate your inventory of all Burn Sheet lots prefixed JT, Stop sales of such product and place in quarantine.\n3.\tIf you have further distributed this product, identify your customers, notify them of these lots being recalled and ask them to return the product for a full refund or replacement.   \n4.\tProduct being recalled that is held in your inventory, as well as returns of that product from your customers, should be shipped to back to Dukal.  Please contact Dukal service at 1-800-243-0741 for an RMA number.  Upon receipt we will issue a full replacement or credit for product returned.  \nAll Product should be returned to the following Address:\nGEODIS \n2385 Tremont Road Savannah, GA 31405 \nTel. : +1 912 232 6125",
      "product_quantity": "12095 cases/12 Packs per case/1 sheet",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of:  CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of  Canada",
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        "device_name": "Sheet, Burn",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5180",
        "device_class": "1"
      }
    }
  ]
}