Gambro Renal Products, Inc.

All catalog numbers involving the Gambro Cartridge Blood Sets: 003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500.

Gastroenterology-Urology Devices

2

No

Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.

Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401

Serial numbers: 0XP15XXXX (all lots)

Gastroenterology-Urology Devices

2

No

Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.

Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.

Serial numbers: 04P158215 and below, 03P158XXX (all lots)

Gastroenterology-Urology Devices

2

No

Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.

Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.