{
  "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": "104215",
      "product_res_number": "Z-0068-2012",
      "event_date_initiated": "2008-03-05",
      "event_date_posted": "2011-10-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-02-19",
      "res_event_number": "60000",
      "product_code": "KGT",
      "product_description": "STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt.  One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'.  The shelf box is placed into a shipping container. \n\nThe Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.",
      "code_info": "Model #SC5000-4R, Lot #090710, Expiration Date:  2009-10",
      "firm_fei_number": "1522875",
      "recalling_firm": "Kapp Surgical Instrument Inc",
      "address_1": "4919 Warrensville Center Rd",
      "city": "Warrensville Heights",
      "state": "OH",
      "postal_code": "44128-4353",
      "additional_info_contact": "216-587-4400",
      "reason_for_recall": "A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration.  However, the shelf box containing the pouches is labeled correctly.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc)  sent a notification letter dated March 5, 2008, to all affected customers.  The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007.  \n\n The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number  1-(800) 282-5277, to call in order to make arrangements for receive replacement  labels for any misbranded packages received.",
      "product_quantity": "59 boxes (3540 units)",
      "distribution_pattern": "Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA",
      "openfda": {
        "registration_number": [
          "3018783057",
          "3042272797",
          "3026331889",
          "3031841433",
          "3013595964",
          "3008559312",
          "3010370474",
          "3045058049",
          "1527607",
          "1043644",
          "3006897996",
          "3010034780",
          "3042277868",
          "3009420598",
          "1055892",
          "3014421917",
          "3013863160",
          "3015058854",
          "3016970619",
          "3041276890",
          "3009303243",
          "1065597",
          "3004361903",
          "3017461134",
          "9680284",
          "3013410562",
          "3009548473",
          "3017194442"
        ],
        "fei_number": [
          "3018783057",
          "3042272797",
          "3026331889",
          "3031841433",
          "3013595964",
          "3008559312",
          "1000111202",
          "3010370474",
          "3045058049",
          "1527607",
          "1043644",
          "3006897996",
          "3010034780",
          "3002805559",
          "3042277868",
          "3009420598",
          "3013863160",
          "3014421917",
          "3015058854",
          "3016970619",
          "3002809016",
          "3041276890",
          "3009303243",
          "3004361903",
          "3017461134",
          "3013410562",
          "3009548473",
          "3017194442"
        ],
        "k_number": [
          "K851612"
        ],
        "device_name": "Drape, Adhesive, Aerosol",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4380",
        "device_class": "1"
      }
    }
  ]
}