Z-0826-2012

NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The...

Name: Z-0826-2012 NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The...
Creator: NxStage Medical, Inc.
Published: 2011-12-14
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2011-12-14 / Terminated / root cause: manufacturing process

FDA source

NxStage Medical, Inc. began a recall of NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the... on 2011-12-14. The reason FDA records is "Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0826-2012
Status: Terminated
Initiated: 2011-12-14
Posted: 2012-01-20
Terminated: 2012-04-17
Recalling firm: NxStage Medical Inc
Product: NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Product code: FKR Subsystem, Proportioning
Reason for recall: Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).
Quantity in commerce: 1,192 devices
Distribution: Nationwide distribution.
Product codes and lots: Lot 1117911, Exp. 2013-09

Product code FKR

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)