{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86804",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.",
      "recall_number": "Z-0607-2021",
      "product_description": "Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045     Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.",
      "product_quantity": "1527",
      "reason_for_recall": "There is an increased likelihood of the introducer sheath separating at the proximal bond site.  If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.",
      "recall_initiation_date": "20201124",
      "center_classification_date": "20201223",
      "termination_date": "20220907",
      "report_date": "20201230",
      "code_info": "Lot Numbers: 13105055, 13124400, 13124401, 13135880, 13138926, 13140911, 13141335, 13162741, 13162742, 13168155, 13168156, 13170665, 13189283, 13214450, 13214451, 13214452, 13214455, 13221812, 13231810, 13237657, 13249434, 13252354, 13252362, 13262332, 13288118, 13291868, 13294511, 13307182, 13315176, 13337784, 13337785, 13337786, 13346090, 13354241, 13357216, 13360416, 13366208, 13366240, 13380385, 13388332"
    }
  ]
}