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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 NxStagesee related information
Date Initiated by FirmJuly 27, 2007
Date PostedSeptember 20, 2007
Recall Status1 Terminated 3 on September 13, 2010
Recall NumberZ-1228-2007
Recall Event ID 38546
510(K)NumberK050525 K061837 
Product Classification hemodialysis cartridge - Product Code KDI
ProductNxStage 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 ContactSame
978-687-4700
Manufacturer Reason
for Recall		Potential for dialysate leaks from the cartridge during treatment.
FDA Determined
Cause 2		Process change control
ActionNxStage 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 Commerce12,085 cases
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KDI
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