{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "219845",
      "product_res_number": "Z-2320-2026",
      "event_date_initiated": "2026-04-24",
      "event_date_posted": "2026-06-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98797",
      "product_code": "DSQ",
      "pma_numbers": [
        "P160035"
      ],
      "product_description": "EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01",
      "code_info": "REF/UDI-DI/serial number:\nP10P-001/04260090040102/2230714, 2230709;\nP30P-001x01/04260090040126/2230254",
      "firm_fei_number": "3004582654",
      "recalling_firm": "BERLIN HEART GMBH",
      "address_1": "Wiesenweg 10 10 wiesenweg",
      "city": "Berlin",
      "country": "Germany",
      "additional_info_contact": "Luis Avila\n281-863-9712",
      "reason_for_recall": "Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.",
      "root_cause_description": "Error in labeling",
      "action": "On 4/24/2026, recall notices were emailed to customers who were asked to do the following:\n\n1) Segregate and discontinue use of any affected unused product.\n2). Notify all appropriate personnel within your organization who need to be aware of this recall.\n3) If any affected devices have been transferred to another facility or customer, promptly forward this notification to those accounts.\n4) Firm will provide replacement products for the affected mislabeled devices and\nwill issue a return shipping label so affected unused products may be returned through\nthe Return Goods Authorization (RGA) process. \n5)  Complete, sign, and return the attached Acknowledgement Form by email to\ninfo@berlinheartinc.com\n\nIf you have questions, contact the firm at info@berlinheartinc.com or 888-826-9466",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the states of MA, SC.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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