Z-0811-2018Class II

NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303...

Name: Z-0811-2018 NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303...
Creator: NxStage Medical, Inc.
Published: 2018-01-29
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2018-01-29 / Terminated / root cause: manufacturing process

FDA source

NxStage Medical, Inc. began a recall of NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF... on 2018-01-29. FDA classified it as Class II and gives the reason as "May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product". 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-0811-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-29
Posted: 2018-03-01
Terminated: 2020-04-03
Recalling firm: NxStage Medical Inc
Product: NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories
Product code: FKR Subsystem, Proportioning
Reason for recall: May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On January 29, 2018 Product Recall Notices & Recall Reply Forms included were emailed to those patients for whom the firm had an email address. Hard copy letters were sent via UPS second day air to patients for whom NxStage did not have an email address. All Dialysis centers were contacted via email. In addition to the active patients and dialysis center consignees of affected product, recall letters were also emailed to the Dialysis Center Home Training Nurse Manager for all active or dropped patients who were shipped affected product, and corporate contacts for national dialysis accounts. Customers are advised to inspect inventory, quarantine, discontinue use and return product. Customers are also encouraged to return the completed Recall Reply Form. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. Customers with questions may call Customer Service at 1-866-697-8243.
Quantity in commerce: 16,039 cases/2 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
Product codes and lots: SAK-301- Lot # 70879245, Exp Date 7/11/2019 SAK-302- Lot # 71079056, Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224, SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019 SAK-306- Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402- Lot # 70879235, Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019 SAK-406- Lot #'s 70979253, Exp Date 7/29/2019 SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0811-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code FKR

K140571Class IINxstage Pureflow SlNxstage Medical, Inc. / cleared 2014-05-15

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)