Class 2 Device Recall High Permeability Hemodialysis System

• Date Initiated by Firm: May 16, 2006
• Date Posted: October 12, 2006
• Recall Status: Terminated on January 03, 2012
• Recall Number: Z-0032-2007
• Recall Event ID: 36199
• 510(K)Number: K041005
• Product Classification: Hemodialysis - Product Code KDI
• Product: Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
• Code Information: Serial numbers: PA0101 to PA0681.
• Recalling Firm/ Manufacturer: Gambro Renal Products, Inc.; 10810 W Collins Ave; Lakewood CO 80215-4439
• For Additional Information Contact: 303-542-5075
• Manufacturer Reason for Recall: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
• FDA Determined Cause: Software design
• Action: Consignees were notified by letter on 05/16/2006.
• Quantity in Commerce: 153 units (US)
• Distribution: Nationwide.
• 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