C.R. Bard, Inc., Urological Division

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.

Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.

Gastroenterology-Urology Devices

1

No

Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.

Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.