{
  "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,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "222193",
      "product_res_number": "Z-3111-2026",
      "event_date_initiated": "2026-08-07",
      "event_date_posted": "2026-09-04",
      "recall_status": "Open, Classified",
      "res_event_number": "99680",
      "product_code": "GBZ",
      "product_description": "Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;\r\nSize(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);",
      "code_info": "1. Model Number(Size): 8016(16FR);\nUDI-DI: 00650862130164;\nLot Number: ME244878;\n\n2. Model Number(Size): 8024(24FR);\nUDI-DI: 00650862130249;\nLot Number: ME244835;\n\n3. Model Number(Size): 8028(28FR);\nUDI-DI: 00650862130287;\nLot Numbers: ME244682, ME244836, ME244837, ME244681;\n\n4. Model Number(Size): 8032(32FR);\nUDI-DI: 00650862130324;\nLot Number: ME244840;\n\n5. Model Number(Size): 8036(36FR);\nUDI-DI: 00650862130362;\nLot Number: ME244686;",
      "firm_fei_number": "3011175548",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "city": "Merrimack",
      "state": "NH",
      "postal_code": "03054-4332",
      "additional_info_contact": "Megan Ties\n603-880-1433",
      "reason_for_recall": "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On August 7, 2026 URGENT MEDICAL DEVICE - RECALL letters were sent to customers. \nCustomer Actions:\n1. Please examine your inventory immediately to determine if you have any of the Atrium PVC Thoracic Catheters with the specific lot numbers.\n2. Should you have any affected product, please remove from area(s) of use and quarantine.\n3. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.\n4. Please contact Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888  9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) and shipping instructions to return any affected product.\n5. Whether or not you have affected product(s) within expiration listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.",
      "product_quantity": "3618",
      "distribution_pattern": "US Nationwide distribution.",
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        ],
        "device_name": "Catheter, Cholangiography",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1"
      }
    }
  ]
}