Gambro Renal Products, Inc.

Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P

Gastroenterology-Urology Devices

2

No

Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.

Gambro Prisma HF1000 preset, Part No. 8399050.

Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P.

Gastroenterology-Urology Devices

2

No

Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.

Gambro Prisma M100 preset, Part No. 8353486.

Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.

Gastroenterology-Urology Devices

2

No

Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.

Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.

Serial numbers: 11637 thru 12321.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico.

Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.

Serial numbers: PA0101 to PA0681.

Gastroenterology-Urology Devices

2

No

Nationwide.

Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.