{
  "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": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Rd",
      "reason_for_recall": "These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed.  The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.",
      "address_2": "",
      "product_quantity": "106",
      "code_info": "UDI: 00886799000533; Serial Numbers: 7919  8165  8166  8167  8168  8169  8170  8173  8174  8175  8176  8179  8180  8181  8182  8183  8184  8185  8186  8187  8188  8189  8190  8191  8192  8193  8194  8195  8196  8197  8198  8199  8200  8201  8202  8203  8204  8205  8206  8207  8208  8209  8210  8211  8212  8213  8214  8215  8216  8217  8218  8219  8220  8221  8222  8223  8224  8225  8226  8227  8228  8229  8230  8231  8232  8233  8234  8235  8236  8237  8241  8242  8243  8244  8251  8253  8254  8255  8256  8257  8258  8259  8260  8261  8262  8263  8264  8265  8266  8267  8268  8269  8270  8271  8273  8274  8275  8276  8280  8307  8308  8309  8310  8311  8313  8335",
      "center_classification_date": "20200207",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.",
      "state": "MI",
      "product_description": "Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-1109-2020",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "84663",
      "termination_date": "20200512",
      "more_code_info": "",
      "recall_initiation_date": "20200110",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}