Device Recall AccuChek

  • Modèle / numéro de série
    Lots 4L157UF, 5A154UF, 5B082UF, 5C148UF, 5C222UF, 5D129UF, 5E158UF, 5F192UF, 5G005UF, 5G104UF, 5H003UF, 5H013UF, 5H088UF, 5H176UF, 5I162UF, 5J010UF, 5J239UF, 5K123UF, 5K141UF, 6A047UF and 6A205UF.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of the U.S. only).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog: 04541405001 and Lots: 5044359, 5061929
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541413001 and lots: 5032437, 5040421, 5053290, and 5065549.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541391001 and lot: 5062206.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541430001 and lots: 5040425, 5044367, 5051305, 5053294, and 5061932.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541448001 and lots: 5040426, 5044368, 5051312, and 5058506.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
68 en plus