Device Recall AccuChek

  • Model / 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..
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog: 04541472001 and lots: 5053291 and 5078661.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    Catalog: 04541456001 and lot: 5052067
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    Catalog: 04541502001 and lots: 5044353, 5046676, 5053301, and 5061934.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    Catalog: 04541499001 and lots: 5051307, 5061935, and 5078667.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
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