{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "85813",
      "product_res_number": "Z-0192-2010",
      "event_date_initiated": "2009-09-25",
      "event_date_posted": "2009-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-12-14",
      "res_event_number": "53543",
      "product_code": "KFM",
      "k_numbers": [
        "K011835"
      ],
      "product_description": "Revolution Blood Pump, \"revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599\"\n\nIntended for use in cardiopulmonary bypass procedures.",
      "code_info": "Lot numbers: 0905220163, 0905220166, 0906240182, and 0906240185.",
      "firm_fei_number": "1718850",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004",
      "additional_info_contact": "800-650-2623",
      "reason_for_recall": "A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.",
      "root_cause_description": "Packaging change control",
      "action": "Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use.  For additional information contact Sorin Group Customer Service at 1-800-650-2623.",
      "product_quantity": "808 units",
      "distribution_pattern": "Worldwide Distribution -- US, Canada, Japan, and Europe.",
      "openfda": {
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          "3006003617",
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        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}