{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "115964",
      "product_res_number": "Z-0902-2013",
      "event_date_initiated": "2013-01-31",
      "event_date_posted": "2013-03-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-15",
      "res_event_number": "64383",
      "product_code": "DTQ",
      "product_description": "Century Console Base, Model #043625051b.  \n\nIntended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.",
      "code_info": "Serial Numbers:  CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.",
      "firm_fei_number": "3001589655",
      "recalling_firm": "Salyer Prn Biomedical",
      "address_1": "1833 W Main St Ste 116 1833 W Main St",
      "address_2": "Ste 116",
      "city": "Mesa",
      "state": "AZ",
      "postal_code": "85201-6924",
      "reason_for_recall": "Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.",
      "root_cause_description": "No Marketing Application",
      "action": "An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine.  The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use.  A refund or credit will be issued for the return of the product.  Customers are instructed to contact Jeff Poland at (314) 497-5232.",
      "product_quantity": "9 units",
      "distribution_pattern": "Distributed in the states of MA,CA, and WI.",
      "openfda": {
        "k_number": [
          "K102726",
          "K070213",
          "K011088",
          "K151349",
          "K090006",
          "K002116",
          "K942582",
          "K052555",
          "K103762",
          "K071318",
          "K153376",
          "K943803",
          "K863541",
          "K022947",
          "K221895",
          "K964017",
          "K092463",
          "K021694",
          "K863960",
          "K080832",
          "K190282",
          "K172220",
          "K221373",
          "K982014",
          "K062396",
          "K163531",
          "K870976",
          "K822068",
          "K002118",
          "K133598",
          "K915183",
          "K813034",
          "K862973",
          "K060053",
          "K232291",
          "K801097",
          "K861388",
          "K950990",
          "K131041",
          "K851614",
          "K091007",
          "K770002",
          "K030141",
          "K772001",
          "K210130",
          "K093882",
          "K202125",
          "K842138",
          "K871131",
          "K020571",
          "K173834",
          "K851615"
        ],
        "registration_number": [
          "1828100",
          "3007427881",
          "1218444",
          "3005941719",
          "3002807090",
          "3001589655",
          "2916596",
          "3010163695",
          "3019807891",
          "3011554160",
          "8010762",
          "3042990265",
          "3010703925",
          "3009507273",
          "2184009",
          "3006073153",
          "9680841",
          "9611109"
        ],
        "fei_number": [
          "3005426550",
          "3009649876",
          "3002808267",
          "1828100",
          "3007427881",
          "1218444",
          "3001589655",
          "2916596",
          "3010163695",
          "3019807891",
          "3006003617",
          "3011554160",
          "3042990265",
          "3010703925",
          "3009507273",
          "3006073153",
          "3002807111",
          "1000116158"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}