Bard

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.

Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.

Gastroenterology-Urology Devices

2

No

Product was distributed Nationwide, Canada, Belgium and Japan

Bard¿ Dimension¿ Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.

Gastroenterology-Urology Devices

2

No

Product was distributed Nationwide, Canada, Belgium and Japan

Bard¿ Platinum Class¿ II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

Catalog Number: 800518, Lot Number: 76IN0317

Gastroenterology-Urology Devices

2

No

AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.

Bardia¿Complete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: ¿5cc Silicone Elastomer-Coated Foley Catheter, ¿Waterproof underpad, ¿Synthetic Vinyl Gloves (2), ¿ Lubricant, ¿10cc Syringe (prefilled with sterile water to inflate Foley catheter), ¿Povidone-Iodine swabs (3), ¿CSR Wrap, ¿Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.

Part Number S-0101; Lot #RR13N101L and RR13N101Q

Radiology Devices

2

Yes

OH, VA

PG910 Spacers, Part number SP101, loaded into Bard¿ Express Seeding Cartridges containing TheraSeed¿ Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.