Device Recall Varta EasyPack XL Lithium Polymer Battery (PoLiFlex)

  • Modelo / Serial
    Batteries coded: XX07 and earlier The Nova Biomedical products that contain the lithium batteries include the following part numbers: Part # 41772 - Battery Assy,  Part # 42215 - Battery Replacement pack,  Part # 42224 - Kit Meter,  Part # 43735 - Kit Meter EZ CHEM,  Part # 43773 - Kit Meter,  Part # 43811 - Battery Replacement Pack EZ CHEM,  Part # 44013 - Kit Meter,  Part # 44014 - Kit Meter and Part # 44251 - Kit Meter.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.
  • Descripción del producto
    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) || Used with: || Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA