Devices

Device Recall Bardex Lubricath

  • Modèle / numéro de série
    Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationwide, Canada, Belgium and Germany.
  • Description du dispositif
    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
    C.R. Bard, Inc., Urological Division
  • 1 Event

Fabricant

C.R. Bard, Inc., Urological Division
  • Adresse du fabricant
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA

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Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter
  • Modèle / numéro de série
    Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    FL, NY, MN and TX Canada, Japan and Taiwan
  • Description du dispositif
    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
  • Manufacturer
    C.R. Bard, Inc.