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Terminated

Prisma continuous renal replacement system.

FDA Recall Z-1545-05 · Posted 2005-10-01

Recalling FirmGambro Renal Products
Recall StatusTerminated
Product CodeKDI
Date Initiated2005-08-16
Date Terminated2012-01-03
Product Quantity1964 units

Reason for Recall

Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

Firm Action

Consignees were notified by press release and letter on 8/16/2005.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010805PRISMA SYSTEMGambro Renal Products · 2002-08-06K993064PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)Gambro Renal Care Products · 1999-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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