{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Rd",
      "reason_for_recall": "During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of  loose fiber particulate that exceeded finished product specifications",
      "address_2": "",
      "product_quantity": "14,380 units",
      "code_info": "Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697, AM006020, AM007724; Part No. 813550, Lot #: AM001312, AM004268, AM007732, AM018316; Part No. 813549, Lot #: AM002717, AM006052, AM007637; Part No. 813552, Lot #: AM003778, AM007725; Part No. 813554, Lot #: AM001309; Part No. 813551, Lot #: AM002702, AM007635; Part No. 813553, Lot #: AM002708; Part No. 813556, Lot #: AM007733; Part No. 813555, Lot #: AM002719; Part No. 813557, Lot #: AM007726; Part No. 813560, Lot #: AM018160; Part No. 813559, Lot #: AM008235; Part No. 813561, Lot #: AM007639; Part No. 813566, Lot #: AM004227, AM017924 & Part No. 813565, Lot #: AM001315, AM006072.",
      "center_classification_date": "20140722",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.",
      "state": "MI",
      "product_description": "Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4\"  & 3/8\" flare,    Product Usage:  Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava",
      "report_date": "20140730",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2103-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68404",
      "termination_date": "20150224",
      "more_code_info": "",
      "recall_initiation_date": "20140523",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}