Device Recall BARDEX

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

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.

CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

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.

Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129

Gastroenterology-Urology Devices

2

No

FL, NY, MN and TX Canada, Japan and Taiwan

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).

Gastroenterology-Urology Devices

2

No

The product was distributed nationwide, Canada, Belgium and Germany.

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.