Device Recall AccuChek

  • Modelo / Serial
    Lots 5C125UF, 5D123UF, 5E113UF, 5E161UF, 5F126UF, 5G031UF, 5I014UF, 5J114UF and 5J219UF.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
  • Descripción del producto
    Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    05075572002, 05075599002, 05075602002, 05075629002, Part numbers: 05180848002, 05075246002, 05075530002, 05075548002, 05075556002, 05075564002 these are not finished device part numbers and were not intended for use in the US.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-USA (nationwide) including the states of AZ, NY, RI, TN, NJ, IN, TX, AL, NV, CA, OR, KY, IL, AR, NM, NE, MD, MO, GA, and SD.
  • Descripción del producto
    ACCU-CHEK Aviva Nano Blood Glucose Meter || No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. || The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
  • Manufacturer
  • Modelo / Serial
    part number 05060311001, 05060303001
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. || Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
  • Manufacturer
  • Modelo / Serial
    Catalog: 04541405001 and Lots: 5044359, 5061929
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK¿ Tender I 13/60 10 pieces || Product Usage: 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: 04541413001 and lots: 5032437, 5040421, 5053290, and 5065549.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender I 13/80 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: 04541391001 and lot: 5062206.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender I 13/110 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
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