Z-1545-05

Prisma continuous renal replacement system

Name: Z-1545-05 Prisma continuous renal replacement system
Creator: Gambro Renal Products
Published: 2005-08-16
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2005-08-16 / Terminated / root cause: software

FDA source

Gambro Renal Products began a recall of Prisma continuous renal replacement system on 2005-08-16. The reason FDA records is "Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1545-05
Status: Terminated
Initiated: 2005-08-16
Posted: 2005-10-01
Terminated: 2012-01-03
Recalling firm: Gambro Renal Products
Product: Prisma continuous renal replacement system.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by press release and letter on 8/16/2005.
Quantity in commerce: 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.
Product codes and lots: Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers.

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)