Class 2 Device Recall Gambro Prismaflex

• Date Initiated by Firm: January 04, 2007
• Date Posted: March 31, 2007
• Recall Status: Terminated on January 03, 2012
• Recall Number: Z-0695-2007
• Recall Event ID: 37306
• 510(K)Number: K041005
• Product Classification: Hemodialysis machine - Product Code KDI
• Product: Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
• Code Information: Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
• Recalling Firm/ Manufacturer: Gambro Renal Products, Inc.; 10810 W Collins Ave; Lakewood CO 80215-4439
• For Additional Information Contact: Tom Dowell; 800-525-2623
• Manufacturer Reason for Recall: Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
• FDA Determined Cause: Device Design
• Action: Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
• Quantity in Commerce: 153 units (Domestic)
• Distribution: Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
• 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 and Original Applicant = GAMBRO RENAL PRODUCTS