Device Recall Triad Alcohol Prep Pads

  • Modelo / Serial
    Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following:  218494,220447,223941,223943,224250,224251,224770,224771,224772,225544,229364,229365, 229366,229367,229368,229369,229370,229371,235188,235189,236334,236335,236336,238868, 238869,239283,239418,239419,239595,243020,243021,243413,243414,243415,243416,243417, 243418,243855,243856,243857,243858,243859,243860,243861,243862,243863,243864,243865, 244432,245759,245760,245761,245762,245763,245764
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
  • Descripción del producto
    0200086, Triad Alcohol Prep Pads, 100 box || 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or || Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; || 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- || Test System; || 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source