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Terminated

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 50 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.

FDA Recall Z-1859-2014 · Posted 2014-06-24

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeFKR
Date Initiated2014-05-14
Date Terminated2017-03-13
Product Quantity2711 cases

Reason for Recall

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Firm 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).

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111174NXSTAGE PUREFLOW SLNxstage Medical, Inc. · 2011-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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