Guidant Corporation Advanced CardiovascularSystem

  • Adresse du fabricant
    Guidant Corporation Advanced CardiovascularSystem, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    Catalog numbers apply in this recall situation as follows: Balloon Diameter (mm) Balloon Length (mm)  8 12 15 20 25 30 1.50 N/A 1011391-12 1011391-15 N/A N/A N/A 2.00 1011392-08 1011392-12 1011392-15 1011392-20 1011392-25 1011392-30 2.25 1011393-08 1011393-12 1011393-15 1011393-20 1011393-25 1011393-30 2.50 1011394-08 1011394-12 1011394-15 1011394-20 1011394-25 1011394-30 2.75 1011395-08 1011395-12 1011395-15 1011395-20 1011395-25 1011395-30 3.00 1011396-08 1011396-12 1011396-15 1011396-20 1011396-25 1011396-30 3.25 1011397-08 1011397-12 1011397-15 1011397-20 1011397-25 1011397-30 3.50 1011398-08 1011398-12 1011398-15 1011398-20 1011398-25 1011398-30  Column at the left represents the diameter. The last tow digits after the hyphen indicate the length.   Lot Numbers  The full list of lot numbers being recalled exceeds 1000. The scope of the recall involves all lots of the sizes given above that have lot numbers in the range:  40101XX through 41231XX, inclusive where XX can be any digits.   For reference lot numbers are date coded: YMMDDLS  Where Y=last digit of year manufactured, MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day, 2= second lot of day).  TO IDENTIFY A UNIQUE PRODUCT ONE NEEDS BOTH THE PART NUMBER AND LOT NUMBER (MULTIPLE PART NUMBERS AER ASSIGNED THE SAME LOT NUMBER PER THE CONVENTION ABOVE.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide. Direct to customers in: Austria, Belgium & Luxumburg, Canada, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, The UK. To Distributors in: Finland, Iceland, Ireland, Lithuania, Barhain, Bulgaria, Cypres, Greece, Hungary, Israel, Jordan, Kuwait, Lebanon, Morocco, Poland, Russia, Saudi Arabia, South Africa, Syria, Tunisia, Turkey, UAE. Also countries in South and Central America although specifics are not known as above. Firm communicated with Competent Authorities in the 30 countries listed above.
  • Description du dispositif
    Voyager RX Coronary Dilatation Catheter