{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Saint Petersburg",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67477",
      "recalling_firm": "Smith & Nephew Inc.",
      "address_1": "970 Lake Carillon Dr",
      "address_2": "Ste 110",
      "postal_code": "33716-1130",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries  Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.",
      "recall_number": "Z-1160-2014",
      "product_description": "Smith & Nephew  RENASYS-Gauze with Soft Port Kit  REF #'s: 66800933, 66800934, 66800935, and 66800936  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)",
      "product_quantity": "498,980 individuals units",
      "reason_for_recall": "Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo",
      "recall_initiation_date": "20140109",
      "center_classification_date": "20140310",
      "termination_date": "20140926",
      "report_date": "20140319",
      "code_info": "ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large"
    }
  ]
}