{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76360",
      "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": "Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom    VA/DOD: Yes",
      "recall_number": "Z-1387-2017",
      "product_description": "Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.",
      "product_quantity": "884",
      "reason_for_recall": "Devices using a specific hemostatic valve design, referred to as a \u001cblue\u001d valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.",
      "recall_initiation_date": "20170201",
      "center_classification_date": "20170302",
      "termination_date": "20180928",
      "report_date": "20170308",
      "code_info": "Catalog Identifier: RCFW-4.0(5.0,6.0,7.0,8.0)- / -BV    Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date:  4826254, RCFW-4.0-35-BV, 2014/03, 3/1/2017; 504036, RCFW-4.0-35-BV, 6/1/2014, 6/1/2017; 5364287, RCFW-4.0-35-BV, 10/15/2014, 10/15/2017; 5379911,  RCFW-4.0-35-BV, 10/21/2014, 10/21/2017; 5400933, RCFW-4.0-35-BV, 10/29/2014, 10/29/2017; 5435105, RCFW-4.0-35-BV, 11/11/2014, 11/11/2017; 5462040,  RCFW-4.0-35-BV, 11/20/2014, 11/20/2017; 5474624, RCFW-4.0-35-BV, 11/25/2014, 11/25/2017; NS5424653, RCFW-4.0-35-BV, 11/6/2014, 11/6/2017; NS5424654, RCFW-4.0-35-BV, 11/6/2014, 11/6/2017; 5213872, RCFW-5.0-35-BV, 8/14/2014, 8/14/2017; 5273219, RCFW-5.0-35-BV, 9/10/2014, 9/10/2017;  5302128,  RCFW-5.0-35-BV, 9/23/2014, 9/23/2017;   5354215,  RCFW-5.0-35-BV,  10/10/2014, 10/10/2017;   5400931, RCFW-5.0-35-BV,  10/29/2014, 10/29/2017;   5523548,  RCFW-5.0-35-BV,  12/17/2014, 12/17/2017;   5681717,  RCFW-5.0-35-BV,  2/26/2015,  2/26/2018;  5690760, RCFW-5.0-35-BV, 3/3/2015, 3/3/2018;  5701193, RCFW-5.0-35-BV, 3/6/2015, 3/6/2018;  6004897, RCFW-5.0-35-BV, 7/2/2015, 7/2/2018;  5260343, RCFW-6.0-35-BV, 9/4/2014, 9/4/2017;  5275648, RCFW-6.0-35-BV, 9/11/2014, 9/11/2017;  5308224, RCFW-6.0-35-BV, 9/24/2014, 9/24/2017;  5312947, RCFW-6.0-35-BV, 9/25/2014, 9/25/2017;  5368247, RCFW-6.0-35-BV, 10/16/2014, 10/16/2017;  5383333, RCFW-6.0-35-BV, 10/22/2014, 10/22/2017;  5444866, RCFW-6.0-35-BV, 11/13/2014, 11/13/2017;  5585193, RCFW-6.0-35-BV, 1/16/2015, 1/16/2018;  5681719, RCFW-6.0-35-BV, 2/26/2015, 2/26/2018;  5690162, RCFW-6.0-35-BV, 3/3/2015, 3/3/2018;  5692849, RCFW-6.0-35-BV, 3/4/2015, 3/4/2018;  5974636, RCFW-6.0-35-BV, 6/20/2015, 6/20/2018;  4906939, RCFW-7.0-35-BV, 2014/04, 4/1/2017;  4987018, RCFW-7.0-35-BV, 5/1/2014, 5/1/2017;  5228810, RCFW-7.0-35-BV, 8/21/2014, 8/21/2017;  5275669, RCFW-7.0-35-BV, 9/11/2014, 9/11/2017;  5301927, RCFW-7.0-35-BV, 9/22/2014, 9/22/2017;  5301930, RCFW-7.0-35-BV, 9/22/2014, 9/22/2017;  5312948, RCFW-7.0-35-BV, 9/25/2014, 9/25/2017;  NS5831881,RCFW-7.0-38-75-RB-HLA-091100-BV, 4/23/2015, 4/23/2018;   NS5878399, RCFW-7.0-38-75-RB-HLA-091100-BV, 5/12/2015, 5/12/2018;  NS5890383, RCFW-7.0-38-75-RB-HLA-091100-BV,5/18/2015, 5/18/2018;  NS5922577,RCFW-7.0-38-75-RB-HLA-091100-BV,6/1/2015, 6/1/2018;   NS6000260, RCFW-7.0-38-75-RB-HLA-091100-BV, 6/30/2015, 6/30/2018;  NS6091893, RCFW-7.0-38-75-RB-HLA-091100-BV, 8/4/2015, 8/4/2018; NS6264206, RCFW-7.0-38-75-RB-HLA-091100-BV, 10/6/2015, 10/6/2018;   F4845598,  RCFW-8.0-35-BV,  2014/03,  3/1/2017;   NS5312949,  RCFW-8.0-35-BV, 9/25/2014, 9/25/2017;  NS5596871, RCFW-8.0-35-BV, 1/21/2015, 1/21/2018; NS5755064, RCFW-8.0-35-BV, 3/26/2015, 3/26/2018;   NS5793423, RCFW-8.0-35-BV, 4/9/2015, 4/9/2018;   NS5831884,RCFW-8.0-38-75-RB-HLA-091100-BV, 4/23/2015, 4/23/2018;  NS5996958 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018;   NS5996959 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018;   NS6002168 RCFW-8.0-38-75-RB-HLA-091100-BV 7/1/2015 7/1/2018;   NS6014785 RCFW-8.0-38-75-RB-HLA-091100-BV 7/7/2015, 7/7/2018; NS6014786, RCFW-8.0-38-75-RB-HLA-091100-BV, 7/7/2015, 7/7/2018; NS6022050,RCFW-8.0-38-75-RB-HLA-091100-BV, 7/10/2015, 7/10/2018; NS6031799,RCFW-8.0-38-75-RB-HLA-091100-BV, 7/14/2015, 7/14/2018; NS6083872, RCFW-8.0-38-75-RB-HLA-091100-BV, 7/31/2015, 7/31/2018; NS6091894, RCFW-8.0-38-75-RB-HLA-091100-BV, 8/4/2015, 8/4/2018; NS6140704, RCFW-8.0-38-75-RB-HLA-091100-BV, 8/20/2015, 8/20/2018; NS6225353, RCFW-8.0-38-75-RB-HLA-091100-BV, 9/22/2015, 9/22/2018; NS6295130, RCFW-8.0-38-75-RB-HLA-091100-BV, 10/19/2015, 10/19/2018  ; NS6329426, RCFW-8.0-38-75-RB-HLA-091100-BV, 10/28/2015, 10/28/2018",
      "more_code_info": ""
    }
  ]
}