{
  "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": "85917",
      "product_res_number": "Z-0272-2010",
      "event_date_initiated": "2009-10-16",
      "event_date_posted": "2009-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-03-16",
      "res_event_number": "53586",
      "product_code": "HGB",
      "pma_numbers": [
        "P870080"
      ],
      "product_description": "Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device;  2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90.\n\nIndicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes",
      "code_info": "lot number 1391, expiry date 02.2010",
      "firm_fei_number": "1418479",
      "recalling_firm": "Richard Wolf Medical Instruments Corp.",
      "address_1": "353 Corporate Woods Pkwy",
      "city": "Vernon Hills",
      "state": "IL",
      "postal_code": "60061-3110",
      "additional_info_contact": "Customer Service\n800-323-9653",
      "reason_for_recall": "The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.",
      "root_cause_description": "Packaging",
      "action": "Richard Wolfe sent recall letters dated October 16,  2009 to the direct accounts via certified mail on the same date.  The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile.  They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement.  The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.",
      "product_quantity": "150 cartons",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "device_name": "Clip, Tubal Occlusion",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5380",
        "device_class": "3"
      }
    }
  ]
}