FDA Medical Device Recalls (openFDA)
Gambro Renal Products: Prisma continuous renal replacement system.
- Recall number
- Z-1545-05
- Recalling firm
- Gambro Renal Products
- Product
- Prisma continuous renal replacement system.
- Status
- Terminated
- Initiated
- 2005-08-16
- Posted
- 2005-10-01
- Terminated
- 2012-01-03
- Reason
- Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
- Root cause
- Software design
- Action
- Consignees were notified by press release and letter on 8/16/2005.
- Quantity
- 1964 units
- Distribution
- Nationwide, including Puerto Rico and Washington, DC. Military consignees in CA and TX. VA consignees in AZ, CA, DC, FL, GA, MO, OH, OR, PA, PR, TX, UT, VA and WI. No foreign distribution by US firm.
- Lot, serial or model codes
- Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers.
- 510(k) numbers
- ["K010805","K993064"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 1713683
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28