{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "104488",
      "product_res_number": "Z-0273-2012",
      "event_date_initiated": "2011-10-05",
      "event_date_posted": "2011-11-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-23",
      "res_event_number": "60123",
      "product_code": "DTS",
      "k_numbers": [
        "K963756"
      ],
      "product_description": "IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE:  18/APR/2015\n\nFor use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.",
      "code_info": "IBC 041811-2065",
      "firm_fei_number": "1000117854",
      "recalling_firm": "International Biophysics Corp",
      "address_1": "2101-2 E Saint Elmo, Ste 275 2101-2 E Saint Elmo",
      "address_2": "Ste 275",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78744",
      "additional_info_contact": "Amy Bertling\n512-814-0070",
      "reason_for_recall": "Potential for the sterility to be compromised.",
      "root_cause_description": "Packaging",
      "action": "International Biophysics Corp. sent a\" Medical Device Recall Notice\" dated October 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.  \n\nUse of the product in the referenced lot number should cease immediately. \n\nCustomers were asked to follow the instructions in the letter to return the affected product.\n\nIf you have any further questions  please call  (512)  814-0070.",
      "product_quantity": "1200 units",
      "distribution_pattern": "Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX",
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          "K905008",
          "K801400",
          "K053021",
          "K891906"
        ],
        "registration_number": [
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          "1928237",
          "1000125147",
          "3003955307",
          "3003944071",
          "1923569",
          "3009513193"
        ],
        "device_name": "Sucker, Cardiotomy Return, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4420",
        "device_class": "2"
      }
    }
  ]
}