{
  "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": "130259",
      "product_res_number": "Z-0059-2015",
      "event_date_initiated": "2014-09-24",
      "event_date_posted": "2014-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-08-11",
      "res_event_number": "69337",
      "product_code": "OWQ",
      "k_numbers": [
        "K110076"
      ],
      "product_description": "Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.",
      "code_info": "Lot Numbers: 1717945, 1721574, 1721575 and 1723123  Catalog Nos: M-5723-115, Model Number BIO10438577",
      "firm_fei_number": "3001237663",
      "recalling_firm": "STERILMED, INC.",
      "address_1": "11400 73rd Ave N",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55369-5561",
      "additional_info_contact": "Biosense Webster sales representative\n763-488-3400",
      "reason_for_recall": "Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne",
      "root_cause_description": "Process control",
      "action": "Sterilmed sent an \"Field Notification\" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nActions requested on your part:\n\n1. Read the Description of the Problem section below carefully.\n2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used.\n3. Maintain a copy of this letter with the affected product.\n4. Review, complete, sign and return the attached Field Removal Certification    Form in accordance with the instructions listed on the form.\n5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form.\n6. Pass on this notice to anyone in your facility that needs to be informed.\n7. If any of the affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return.\n8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster.\n\nFor questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.",
      "product_quantity": "22",
      "distribution_pattern": "US Distribution including the states of WA and CA.",
      "openfda": {
        "k_number": [
          "K230584",
          "K043453",
          "K202042",
          "K232130",
          "K231621",
          "K173262",
          "K250545",
          "K063076",
          "K250592",
          "K190478",
          "K234064",
          "K170474",
          "K210655",
          "K121913",
          "K092425",
          "K230934",
          "K230928",
          "K231588",
          "K153090",
          "K161700",
          "K243101",
          "K254149",
          "K232584",
          "K033436",
          "K222217",
          "K223026",
          "K110076",
          "K182238",
          "K163560",
          "K181126",
          "K012537"
        ],
        "device_name": "Reprocessed Intravascular Ultrasound Catheter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2",
        "registration_number": [
          "3011276773",
          "2011171",
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        ],
        "fei_number": [
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          "3002615969"
        ]
      }
    }
  ]
}