{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "86001",
      "product_res_number": "Z-0317-2010",
      "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": "32CM DECATHLON GOLD FUNNEL TIP STD KIT\nModel: DFC27SH32\n\n15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic\nhemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch\nguidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free",
      "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": "567 units",
      "distribution_pattern": "Worldwide distribution - Nationwide, Government. Foreign: Canada, France.",
      "openfda": {
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        "device_name": "Catheter, Hemodialysis, Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      }
    }
  ]
}