{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205668",
      "product_res_number": "Z-0977-2024",
      "event_date_initiated": "2024-01-08",
      "event_date_posted": "2024-02-02",
      "recall_status": "Open, Classified",
      "res_event_number": "93852",
      "product_code": "KFM",
      "k_numbers": [
        "K080470"
      ],
      "product_description": "BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.",
      "code_info": "UDI-DI 4037691530864\n\nLots 3000286570 and 3000325568\n\n***Lots added 3/21/24***\n3000341070;\n3000355577;\n3000358977",
      "firm_fei_number": "3008355164",
      "recalling_firm": "Maquet Medical Systems USA",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "additional_info_contact": "Charles Ryan\n973-709-7000",
      "reason_for_recall": "Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.",
      "root_cause_description": "Process control",
      "action": "On January 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letters.\n\nCustomers were instructed to remove all affected RF-32 pumps from use. If product is already in use, the firm advised to not discontinue therapy, but to monitor the patient closely for signs of infection.\n\nCustomers should quarantine all affected product and return unopened/unexpired affected product to MCP/Getinge.\n\nPlease contact MCP/Getinge Customer\nSupport at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00\na.m. and 6:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) number and\nshipping instructions.\n\nDistributors should forward the recall document to customers who received affected products.\n\nInformation also posted on firm's website: https://www.getinge.com/us/products-and-solutions/cardiovascular-procedures/\n\n***Updated 3/21/24***\nFirm expanded field action to include additional lots. Amended notifications were sent to affected US customers on March 20, 2024.",
      "product_quantity": "1090 total",
      "distribution_pattern": "Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, \nPA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.",
      "openfda": {
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          "K080470",
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          "K884659",
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          "K133265",
          "K842007",
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          "K933014",
          "K193663",
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          "K882129",
          "K020998",
          "K912604",
          "K111972",
          "K915363",
          "K900601",
          "K111384",
          "K030462",
          "K132712",
          "K220842"
        ],
        "registration_number": [
          "3014990448",
          "3030125051",
          "3011554160",
          "1928237",
          "3003306248",
          "8010026",
          "2528981",
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          "2916596",
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          "1124841",
          "3006073153",
          "1123137",
          "2011171",
          "3005941719",
          "3019807891",
          "9681834",
          "3016746283",
          "8010762",
          "2029275",
          "3010163695",
          "9680841",
          "3007427881",
          "3006849754",
          "3009507273"
        ],
        "fei_number": [
          "3014990448",
          "3030125051",
          "3002534070",
          "3005426550",
          "3011554160",
          "1928237",
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          "1000514656",
          "3006073153",
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          "2011171",
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          "3010163695",
          "3009649876",
          "3007427881",
          "3006849754",
          "3006003617",
          "3009507273"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}