{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "73686",
      "product_res_number": "Z-0558-2009",
      "event_date_initiated": "2008-08-08",
      "event_date_posted": "2009-01-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-04-26",
      "res_event_number": "49510",
      "product_code": "NML",
      "k_numbers": [
        "K012556"
      ],
      "product_description": "Guidewires - Endoscopic (Jag Wires)\t\t\nModel #'s: \nMIC5658 and\nMIC630-100\nIntended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges.",
      "code_info": "n/a",
      "firm_fei_number": "3001237663",
      "recalling_firm": "Sterilmed Inc",
      "address_1": "11400 73rd Ave N Ste 100 11400 73rd Ave N",
      "address_2": "Ste 100",
      "city": "Osseo",
      "state": "MN",
      "postal_code": "55369-5562",
      "additional_info_contact": "763-488-3400",
      "reason_for_recall": "SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch.  The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end.\n\nA breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable",
      "root_cause_description": "Packaging process control",
      "action": "Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08.  SteriMed also provided consignees (Materials Manager/Risk Manager) with a \"Urgent Product Removal\" recall letter (August 14, 2008) in person informing them of the potential of  receiving affected product.  Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned.  Contact SterilMed, Inc. at 1-888-541-0078 for assistance.",
      "product_quantity": "2",
      "distribution_pattern": "AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV  OUS: CANADA",
      "openfda": {
        "k_number": [
          "K012556"
        ],
        "device_name": "Catheter, Biliary, Reprocessed",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5010",
        "device_class": "2"
      }
    }
  ]
}