Class 1 Device Recall Continuous renal replacement system.

• Date Initiated by Firm: August 16, 2005
• Date Posted: October 01, 2005
• Recall Status: Terminated on January 03, 2012
• Recall Number: Z-1545-05
• Recall Event ID: 33120
• 510(K)Number: K010805 K993064
• Product Classification: dialysis - Product Code KDI
• Product: Prisma continuous renal replacement system.
• Code Information: Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers.
• Recalling Firm/ Manufacturer: Gambro Renal Products; 10810 W Collins Ave; Lakewood CO 80215-4439
• For Additional Information Contact: 800-525-2623
• Manufacturer Reason for Recall: Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI; 510(K)s with Product Code = KDI