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U.S. Department of Health and Human Services

Class 3 Device Recall NxStage System One

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  Class 3 Device Recall NxStage System One see related information
Date Initiated by Firm April 14, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 13, 2004
Recall Number Z-1069-04
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-124, 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 2		 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 234 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 and Original Applicant = NXSTAGE MEDICAL, INC.
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