{
  "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": "86577",
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "address_1": "45 Barbour Pond Dr",
      "address_2": "",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France,  Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia, Malta, Netherlands, Norway, Pakistan, Peru, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden,  Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.",
      "recall_number": "Z-0443-2021",
      "product_description": "Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).",
      "product_quantity": "51 units",
      "reason_for_recall": "The Printed Circuit Board Assembly  (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed  circuit board (PCB) where as the standard requires a creepage distance of 4 mm.",
      "recall_initiation_date": "20200930",
      "center_classification_date": "20201112",
      "termination_date": "20230525",
      "report_date": "20201118",
      "code_info": "Serial numbers 90002022 90002134 90002163 90002187 90002276 90002297  90002023 90002135 90002164 90002188 90002277 90002298  90002024 90002136 90002168 90002191 90002279 90002302  90002029 90002137 90002170 90002194 90002280 90002306  90002047 90002140 90002172 90002195 90002281 90002312  90002112 90002143 90002181 90002196 90002287 90002313  90002123 90002144 90002183 90002210 90002289  90002124 90002160 90002184 90002212 90002293  90002133 90002161 90002185 90002273 90002296",
      "more_code_info": ""
    }
  ]
}