Devices

Device Recall BARDEX

  • Model / Serial
    Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • Manufacturer
    C.R. Bard, Inc.
  • 1 Event

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall BARDEX
  • Model / Serial
    Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall BARDEX
  • Model / Serial
    CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter
  • Model / Serial
    Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
  • Product Classification
    Gastroenterology-Urology Devices
  • 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
    C.R. Bard, Inc.
Device Recall Bardex Lubricath
  • Model / Serial
    Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
  • Product Classification
    Gastroenterology-Urology Devices
  • 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
    C.R. Bard, Inc., Urological Division