Device Recall AccuChek

  • Modelo / Serial
    Lots 2J081UF, 2J066UF, 2K032UF, 2K050UF, 2K057UF, 2L009UF, 2L079UF, 3A002UF, 3A028UF, 3B011UF, 3C047UF, 3D139UF, 3F074UF, 3F084UF, 3F117UF, 3G025UF, 3G039UF, 3G064UF, 3G084UF, 3G151UF, 3H026UF, 3H034UF, 3H058UF, 3I117UF, 3J048UF, 3K001UF, 3K084UF, 3L079UF, 4A107UF, 4A116UF, 4C133UF, 4C153UF, 4C156UF, 4D133UF, 4E118UF, 4F005UF, 4F135UF, 4F180UF, 4G159UF, 4H066UF, 4H149UF, 4I048UF, 4J004UF, 4J148UF, 4K065UF, 4L079UF, 5B005UF, 5C191UF, 5E070UF, 5F148UF, 5G187UF, 5I092UF, 5I204UF, 5J195UF, 5K027UF, 5L005UF and 6B078UF..
  • 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-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
  • 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
    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
  • Modelo / Serial
    Catalog: 04541430001 and lots: 5040425, 5044367, 5051305, 5053294, and 5061932.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender I 17/60 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: 04541448001 and lots: 5040426, 5044368, 5051312, and 5058506.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    ACCU-CHEK Tender I 17/80 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
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