{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "94382",
      "product_res_number": "Z-0011-2011",
      "event_date_initiated": "2010-09-07",
      "event_date_posted": "2010-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-09-25",
      "res_event_number": "56728",
      "product_code": "DWE",
      "k_numbers": [
        "K080592"
      ],
      "product_description": "MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400",
      "code_info": "Lot number 70052718 and 70048867",
      "firm_fei_number": "3008355164",
      "recalling_firm": "Maquet Inc.",
      "address_1": "45 Barbour Pond Drive",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470",
      "additional_info_contact": "Ms. Susan Mandy\n973-995-8968",
      "reason_for_recall": "Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.",
      "root_cause_description": "Device Design",
      "action": "Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions.  All firms are to coomplete and return the Corrective Action Response Form.\nMaquet Customer Service can bre contacted at 800-777-4222.",
      "product_quantity": "22 items",
      "distribution_pattern": "Worldwide Distribution: USA State of IL and country of the  Netherlands.",
      "openfda": {
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          "K800178",
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          "K842044",
          "K902845",
          "K801394",
          "K803277",
          "K993189",
          "K092486"
        ],
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          "3019807891",
          "1124841",
          "1319211",
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        "device_name": "Tubing, Pump, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4390",
        "device_class": "2"
      }
    }
  ]
}