Device Recall AccuChek

  • Modèle / numéro de série
    Lots 31037UF, 31053UF, 31074UF, 31103UF, 3C130UF, 3D055UF, 3F060UF, 3F061UF, 3F095UF, 3G052UF, 3G127UF, 3I153UF, 3J068UF, 3J163UF, 3K047UF, 3K126UF, 3L144UF, 4B033UF, 4D044UF, 4E014UF, 4E141UF, 4F051UF, 4G035UF, 4G050UF, 4H159UF, 4H234UF, 4I056UF, 4I195UF, 4J076UF, 4K016UF, 4K164UF, 5C042UF, 5D211UF, 5E005UF, 5F074UF, 5H097UF, 5I056UF, 5I132UF, 5J149UF, 5K024UF, 5K176UF and 6B108UF.
  • 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 Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the 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: 04541472001 and lots: 5053291 and 5078661.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541456001 and lot: 5052067
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541502001 and lots: 5044353, 5046676, 5053301, and 5061934.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog: 04541499001 and lots: 5051307, 5061935, and 5078667.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
68 en plus