{
  "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": [
    {
      "status": "Ongoing",
      "city": "Pittsburgh",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88972",
      "recalling_firm": "Cardiac Assist, Inc",
      "address_1": "240 Alpha Dr",
      "address_2": "",
      "postal_code": "15238-2906",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Distribution to states of: DC, MA, SC, and VA.",
      "recall_number": "Z-0311-2022",
      "product_description": "SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap.  Kit Number: 5820-3118  Intended use is applicable to the intended use of specific devices included in the kit.",
      "product_quantity": "7 units",
      "reason_for_recall": "Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)",
      "recall_initiation_date": "20211014",
      "center_classification_date": "20211129",
      "report_date": "20211208",
      "code_info": "Serial Numbers:  872170,  872171,  872172,  872173,  872182,  872183,  872184.   UDI:    01)00814112020791(17)220 501(22)220511(21) 872170;  (01)00814112020791(17)220 501(22)220511(21) 872171;  (01)00814112020791(17)220 501(22)220511(21) 872172;  (01)00814112020791(17)220 501(22)220511(21) 872173;  (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184",
      "more_code_info": ""
    }
  ]
}