{
  "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": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86796",
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "address_1": "45 Barbour Pond Dr",
      "address_2": "N/A",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.",
      "recall_number": "Z-0632-2021",
      "product_description": "HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.",
      "product_quantity": "58,438 devices worldwide",
      "reason_for_recall": "The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.",
      "recall_initiation_date": "20201120",
      "center_classification_date": "20201217",
      "termination_date": "20241107",
      "report_date": "20201223",
      "code_info": "Model Number: BEQ-HLS 5050  Part Number: 70105.2797  UDI Code: 04037691773513  Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921,  70127922, 70127923, 70127924, 70128195, 70128196,  70128197, 70128328, 70128329, 70128330, 70128331,  70129242, 70129243, 70129244, 70129245, 70129380,  70129381, 70129382, 70129383, 70129469, 70129470,  70129471, 70129472, 70129556, 70129557, 70129558,  70129559, 70129634, 70129635, 70129637, 70129638,  70129849, 70129850, 70130071, 70130072, 70130207,  70130208, 70130209, 70130883, 70130884, 70130885,  70130886, 70131090, 70131091, 70131092, 70131093,  70131159, 70131160, 70131161, 70131162, 70131405,  70131406, 70131407, 70131408, 70131474, 70131475,  70131587, 70131588, 70131589, 70131590, 70131976,  70131977, 70131978, 70131979, 70132435, 70132652,  70132653, 70132845, 70132861, 70132862, 70132903,  70132904, 70133056, 70133057, 70133102, 70133103,  70133472, 70133473, 70133474, 70133475, 70133528,  70133634, 70133636, 70133637, 70133751, 70133752,  70133753, 70133754, 70133755, 70133756, 70133757,  70133758, 70133759, 70133760, 70133761, 70133762,  70133763, 70133764, 70134019, 70134020, 70134021,  70134022, 70134023, 70134025, 70134028, 70134750,  70134751, 70134752, 70134753, 70134754, 70134755,  70135250, 70135251, 70135252, 70135253, 70135254,  70135255, 70135256, 70135257, 70135258, 70136150,  70136151, 70136152"
    }
  ]
}