Class 3 Device Recall NxStage System One

• Date Initiated by Firm: April 14, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 13, 2004
• Recall Number: Z-1071-04
• Recall Event ID: 29268
• 510(K)Number: K040696
• Product Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
• Product: NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.
• Code Information: Lot Numbers from and including FG-031216-01 to FG-040322-01
• Recalling Firm/ Manufacturer: NxStage Medical, Inc.; 439 South Union Street, 5th Floor; Lawrence MA 01843-2800
• For Additional Information Contact: Michael J. Webb; 978-687-4736
• Manufacturer Reason for Recall: Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate
• FDA Determined Cause: Other
• Action: Voluntary recall notice dated 4/14/04 sent UPS, overnight with signature required to both ICU/CCU (Acute accounts) and Chronic accounts. Firm to remove and replace product that contains a disposable component from a new supplier that has demonstrated to be less reliable resulting in pinhole leaks.
• Quantity in Commerce: 552 units
• Distribution: CA, IL, IN, MD, IA, MO, NJ, OH, VT
• 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