Z-1228-2007

NxStage Cartridge Express, CAR-170, for hemodialysis

Name: Z-1228-2007 NxStage Cartridge Express, CAR-170, for hemodialysis
Creator: NxStage Medical, Inc.
Published: 2007-07-27
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2007-07-27 / Terminated

FDA source

NxStage Medical, Inc. began a recall of NxStage Cartridge Express, CAR-170, for hemodialysis on 2007-07-27. The reason FDA records is "Potential for dialysate leaks from the cartridge during treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1228-2007
Status: Terminated
Initiated: 2007-07-27
Posted: 2007-09-20
Terminated: 2010-09-13
Recalling firm: NxStage Medical Inc
Product: NxStage Cartridge Express, CAR-170, for hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential for dialysate leaks from the cartridge during treatment.
FDA root cause: 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
Product codes and lots: 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.

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)