{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85975",
      "product_res_number": "Z-0291-2010",
      "event_date_initiated": "2009-10-23",
      "event_date_posted": "2009-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-06-09",
      "res_event_number": "53605",
      "product_code": "MSD",
      "k_numbers": [
        "K032061",
        "K040509",
        "K042858",
        "K060155",
        "K063431",
        "K063441"
      ],
      "product_description": "36CM DECATHLON STD KIT\nModels: DE31SH36 and DE31SH36-K\n15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit  28cm Decathlon Std Kit.",
      "code_info": "All lot codes",
      "firm_fei_number": "1000159376",
      "recalling_firm": "Spire Biomedical, Inc.",
      "address_1": "One Patriots Park",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2343",
      "additional_info_contact": "Edward Rule\n617-275-6000 Ext. 274",
      "reason_for_recall": "There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira",
      "root_cause_description": "Process control",
      "action": "Spire Medical issued an \"Urgent device Recall\" letter dated 10/22/09 by FEDEX to end users.  Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.",
      "product_quantity": "930 units",
      "distribution_pattern": "Worldwide distribution - Nationwide, Government. Foreign: Canada, France.",
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        "device_name": "Catheter, Hemodialysis, Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      }
    }
  ]
}