Device Recall Bardex Lubricath

  • Model / Serial
    Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide, Canada, Belgium and Germany.
  • Product Description
    Bardex¿ Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, NY, MN and TX Canada, Japan and Taiwan
  • Product Description
    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
  • Manufacturer