{
  "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": "Brooklyn Park",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87271",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "address_2": "N/A",
      "postal_code": "55428-1088",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US nationwide, Afghanistan,  Argentina,  Chile,  China,  Colombia,  Egypt,  Germany,  Iraq,  Italy,  Japan,  Korea,  Kyrgyzstan,  Latvia,  Nicaragua,  Paraguay,  Poland,  Qatar,  Romania,  Tanzania,  United Arab Emirates,  United Kingdom,  Uzbekistan, and Viet Nam",
      "recall_number": "Z-1190-2021",
      "product_description": "Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface  (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and  adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).",
      "product_quantity": "2,374 units",
      "reason_for_recall": "Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.",
      "recall_initiation_date": "20210204",
      "center_classification_date": "20210317",
      "termination_date": "20240426",
      "report_date": "20210324",
      "code_info": "Description: OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU. Model Number: BBP241. GTIN: 20613994746508 and ***UPDATE GTIN 00643169089037***:  Lot Numbers: 13344059, 13337110, 13337675, 13339043, 13339133, 13339290, 13339452, 13339527, 13344325, 13344487, 13344594, 13344819, 13346564, 13346733, 13347774, 13347907, 13347974, 13348151, 13348285, 13348909, 13348974, 13349283, 13349388, 13349517, 13349775, 13352983, 13353438, 13353541, 13353701, 13353800, 13337512, 13340766, 13342814, 13346440, 13348521, 13349141, 13352832, 13353163, ***UPDATE 13340871***."
    }
  ]
}