Z-1857-2014Class II

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2...

Name: Z-1857-2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2...
Creator: NxStage Medical, Inc.
Published: 2014-05-14
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2014-05-14 / Terminated / root cause: manufacturing process

FDA source

NxStage Medical, Inc. began a recall of NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101... on 2014-05-14. FDA classified it as Class II and gives the reason as "SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification". 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-1857-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-14
Posted: 2014-06-24
Terminated: 2017-03-13
Recalling firm: NxStage Medical Inc
Product: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
Product code: FKR Subsystem, Proportioning
Reason for recall: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
Quantity in commerce: 16,625 cases
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Product codes and lots: Lot code: 40179091 40179069 40179068 40179029 40179019 31279094 3067901 3057932 3057919 3057918 3057909 3057908

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1857-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1854-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1855-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1856-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1857-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1858-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1859-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1860-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1861-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24

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)