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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage

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  Class 2 Device Recall NxStage see related information
Date Initiated by Firm July 27, 2007
Date Posted September 20, 2007
Recall Status1 Terminated 3 on September 13, 2010
Recall Number Z-1228-2007
Recall Event ID 38546
510(K)Number K061837  K050525  
Product Classification hemodialysis cartridge - Product Code KDI
Product NxStage Cartridge Express, CAR-170, for hemodialysis.
Code Information Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703.
Recalling Firm/
Manufacturer
NxStage Medical, Inc.
439 South Union Street, 5th Floor
Lawrence MA 01843-2800
For Additional Information Contact Same
978-687-4700
Manufacturer Reason
for Recall
Potential for dialysate leaks from the cartridge during treatment.
FDA Determined
Cause 2
Process change control
Action NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.
Quantity in Commerce 12,085 cases
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 and Original Applicant = NXSTAGE MEDICAL, INC.
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