{
  "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": "Eden Prairie",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72913",
      "recalling_firm": "Acist Medical Systems",
      "address_1": "7905 Fuller Rd",
      "address_2": "N/A",
      "postal_code": "55344-2137",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.",
      "recall_number": "Z-0744-2016",
      "product_description": "ACIST Medical Systems, BT2000 Automated Manifold Kit   (SKU 014613) and CPT2000 (SKU 014623)  Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico.    The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST).    To be used for the controlled infusion of radiopaque contrast media for angiographic procedures",
      "product_quantity": "48,614 cartons or  486,140 units",
      "reason_for_recall": "Reports related to ingress of air into the manifold.",
      "recall_initiation_date": "20151221",
      "center_classification_date": "20160202",
      "termination_date": "20160722",
      "report_date": "20160210",
      "code_info": "Lot Number    08915J  09015T  09115H  09315D  09615N  09615U  09715X  09815F  10115D  10215G  10415D  10415W  10415Y  10515P  11015L  11115K  11215U  11315M  11715J  11815G  11915D  12415J  12615P  13115M  13415W  13815G  13915T  14015P  14115M  14615D  14615M  15415G  15715D  16115H  16315L  16515E  16615Z  16815J  16915N  17115F  17615U  17815F  18215J  18415D  18515N  18715U  18815K  18915P  19015N  19115H  19315D  19415P  19515X  19715G  19815M  19915D  20115M  20315E  20715D  20815M  20915X  21115W  21815J  21815U  22015D  23715D  23815D  23815P  24415P  24615U  25015D  25515D  26415N  26715F  26815J  26815K  27115L  27215U  27315Z  27415H  27515D  29115D  29915E  29915F  30015E  30015F  32115M  32715G  32715V  32815M",
      "more_code_info": ""
    }
  ]
}