{
  "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": [
    {
      "country": "United States",
      "city": "Wayne",
      "address_1": "45 Barbour Pond Drive",
      "reason_for_recall": "A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.",
      "address_2": "",
      "product_quantity": "10, 199 units",
      "code_info": "Part numbers BEQ-HLS 5050, 70105,2797, BEQ-HLS 7050, 70105.2794, and BO-HLS 7050,  70105.2786",
      "center_classification_date": "20150528",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia Montenegro, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and Uruguay",
      "state": "NJ",
      "product_description": "HLS/HIT Set Advanced with Bioline and/or Softline Coating Console      Product Usage:  HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.",
      "report_date": "20150603",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "recall_number": "Z-1690-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70681",
      "termination_date": "20190118",
      "more_code_info": "",
      "recall_initiation_date": "20150305",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}