Device Recall ACCUCHEK Tender II Infusion Set

  • Modelo / Serial
    Catalog: 04541472001 and lots: 5053291 and 5078661.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 13/80 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog: 04541456001 and lot: 5052067
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 13/110 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
  • Modelo / Serial
    Catalog: 04541502001 and lots: 5044353, 5046676, 5053301, and 5061934.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 17/60 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
  • Modelo / Serial
    Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 17/80 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
  • Modelo / Serial
    Catalog: 04541499001 and lots: 5051307, 5061935, and 5078667.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 17/110 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
  • Modelo / Serial
    Catalog: 04541464001 and lots: 5044364 and 5058502.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender II 13/60 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer