FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, 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.
- Recall number
- Z-1854-2014
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, 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.
- Status
- Terminated
- Initiated
- 2014-05-14
- Posted
- 2014-06-24
- Terminated
- 2017-03-13
- Reason
- SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- 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
- 13474 cases
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
- Lot, serial or model codes
- Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928
- 510(k) numbers
- ["K111174","K140571"]
- PMA numbers
- not on file
- Product code
- FKR
- Firm FEI
- 3003464075
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28